FDA 510(k) Applications for Medical Device:
Generator, Oxygen, Portable
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K991569 | 02 MARKETING GROUP, INC. |
11285 ELKINS RD. | ROSWELL | GA | 30076 |
| K200496 | 3B Medical Inc. |
203 Avenue A NW, Suite 300 | Winter Haven | FL | 33881 |
| K960309 | AIRSEP CORP. |
290 CREEKSIDE DR. | BUFFALO | NY | 14228 |
| K101154 | AIRSEP CORP. |
401 CREEKSIDE DR. | BUFFALO | NY | 14228-2085 |
| K012037 | AIRSEP CORP. |
290 CREEKSIDE DR. | BUFFALO | NY | 14228 |
| K020324 | AIRSEP CORP. |
290 CREEKSIDE DR. | BUFFALO | NY | 14228 |
| K150930 | AirSep Corporation |
260 Creekside Drive | Buffalo | NY | 14228 |
| K971129 | ARBOR RESEARCH CORP. |
806 AIRPORT BLVD. | ANN ARBOR | MI | 48108 |
| K203086 | Belluscura LLC |
5504 Democracy Dr, Suite 200 | Plano | TX | 75024 |
| K121167 | CAIRE INC. |
2200 AIRPORT INDUSTRIAL DRIVE | BALL GROUND | GA | 30107 |
| K250671 | CAIRE Inc. |
2200 Airport Industrial Drive, Ste 500 | Ball Ground | GA | 30107 |
| K120785 | CAIRE, INC. |
12230 WORLD TRADE | SAN DIEGO | CA | 92128 |
| K982243 | CANOGEN INTERNATIONAL LTD. |
14900 SWEITZER LN. | LAUREL | MD | 20707 |
| K071904 | CARLETON LIFE SUPPORT SYSTEMS INC. |
2734 HICKORY GROVE RD. | DAVENPORT | IA | 52804-1203 |
| K051887 | CARLETON LIFE SUPPORT SYSTEMS INC. |
2734 HICKORY GROVE RD. | DAVENPORT | IA | 52804-1203 |
| K971889 | CHAD THERAPEUTICS, INC. |
21622 PLUMMER ST. | CHATSWORTH | CA | 91311 |
| K013472 | CHAD THERAPEUTICS, INC. |
21622 PLUMMER ST. | CHATSWORTH | CA | 91311 |
| K981047 | COLORADO MEDTECH, INC. |
6175 LONGBOW DR. | BOULDER | CO | 80301 |
| K180837 | Contec Medical System Co., Ltd. |
No. 112 Qinhuang West Street, Economic & Technical | Qinhuangdao | 066004 | |
| K071461 | COPD PARTNERS, INC. |
3460 POINTE CREEK CT. | BONITA SPRINGS | FL | 34134-2015 |
| K090007 | DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD. |
NO.89 SHUANGFENG ROAD, | DANYANG CITY,JIANGSU PROVINCE | 212300 | |
| K073242 | DELPHI MEDICAL SYSTEMS |
5725 DELPHI DRIVE | TROY | MI | 48098 |
| K172648 | DeVilbiss Healthcare, LLC |
100 DeVilbiss Drive | Somerset | PA | 15501 |
| K043520 | EMG TECHNOLOGY CO., LTD. |
914 WEST PATAPSCO AVE. | BALTIMORE | MD | 21230 |
| K984081 | EMOX 911 CC |
P.O. BOX 79 | SOMERSET WEST | 7129 | |
| K131990 | ESSEX CRYOGENICS OF MISSOURI, INC. |
8007 CHIVVIS DR. | ST. LOUIS | MO | 63123 |
| K022684 | ESSEX CRYOGENICS OF MISSOURI, INC. |
8007 CHIVVIS DR. | ST. LOUIS | MO | 63123 |
| K102245 | FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. |
KEJIMAN 12 ROAD, HI-TEC IND PK | NANSHAN, SHENZHEN | 518057 | |
| K240840 | Foshan Care Medical Technology Co., Ltd. |
#2 Haitang Rd, National Ecological Industrial Park Danzao | Foshan | 528000 | |
| K202389 | Foshan MIC Medical Technology Co., LTD |
U501-1,503, 5F, No.7 Building, Zone A Hantian | Foshan | 528200 | |
| K102750 | GETO2, INC. |
24301 WOODSAGE DRIVE | BONITA SPRINGS | FL | 34134 |
| K191875 | Guangzhou Life Light Electronic Technology Co., Ltd. |
No. A102, No. 1 Kesheng Road, Baiyun District | GUangzhou | 510540 | |
| K972614 | HEALTHDYNE TECHNOLOGIES, INC. |
1255 KENNESTONE CIR. | MARIETTA | GA | 30066 |
| K004047 | IN-X CORP. |
6753 EAST 47TH AVE. | DENVER | CO | 80216 |
| K042944 | IN-X CORPORATION |
6753 EAST 47TH AVE. | DENVER | CO | 80216 |
| K222086 | Inogen |
301 Coromar Drive | Goleta | CA | 93117 |
| K230052 | Inogen, Inc |
301 Coromar Drive | Goleta | CA | 93117 |
| K132489 | INOGEN, INC. |
326 BOLLAY DRIVE | GOLETA | CA | 93117 |
| K032818 | INOGEN, INC. |
120 CREMONA DRIVE | GOLETA | CA | 93117 |
| K132205 | INOVA LABS, INC. |
2800 PLEASANT HILL RD., SUITE 175 | PLEASANT HILL | CA | 94523 |
| K113317 | INOVA LABS, INC. |
3500 COMSOUTH DR. | AUSTIN | TX | 78744 |
| K141967 | INOVO, INC. |
401 Leonard Blvd N | Lehigh Acres | FL | 33971 |
| K072688 | INTERNATIONAL BIOPHYSICS CORP. |
2101-2 E. ST. ELMO | AUSTIN | TX | 78744 |
| K020386 | INVACARE CORP. |
ONE INVACARE WAY | ELYRIA | OH | 44036-2125 |
| K983777 | INVACARE CORP. |
ONE INVACARE WAY | ELYRIA | OH | 44036 |
| K071928 | INVACARE CORP. |
ONE INVACARE WAY | ELYRIA | OH | 44036-2125 |
| K003939 | INVACARE CORP. |
ONE INVACARE WAY | ELYRIA | OH | 44036-2125 |
| K021685 | INVACARE CORP. |
ONE INVACARE WAY | ELYRIA | OH | 44036-2125 |
| K983627 | INVACARE CORP. |
ONE INVACARE WAY | ELYRIA | OH | 44036-2125 |
| K191159 | Invacare Corporation |
One Invacare Way | Elyria | OH | 44035 |
| K200890 | Invacare Corporation |
One Invacare Way | Elyria | OH | 44035 |
| K203210 | Invacare Corporation |
One Invacare Way | Elyria | OH | 44035 |
| K160630 | INVACARE CORPORATION |
ONE INVACARE WAY | ELYRIA | OH | 44035 |
| K083751 | INVACARE CORPORATION |
ONE INVACARE WAY | ELYRIA | OH | 44036-2125 |
| K230969 | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. |
No.36 Danyan Road | Danyang | 212300 | |
| K223740 | Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. |
NO.8, Shengchang West Road, | Jiangsu | 212300 | |
| K213825 | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. |
No. 1 Baisheng Road, Development Zone, | Danyang | 212300 | |
| K242736 | Jiangsu Yuyue Medical Equipment & Supply Co., LTD. |
No.1 Baisheng Road Development Zone | Danyang | 212300 | |
| K083559 | JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. |
9109 COPENHAVER DR. | POTOMAC | MD | 20854 |
| K081267 | KEDL INTERNATION LIMITED |
7690 CAMERON CIRCLE | FORT MYERS | FL | 33912 |
| K013223 | LITTON SYSTEMS, INC. |
2734 HICKORY GROVE RD. | DAVENPORT | IA | 52804-1203 |
| K131968 | LONGFIAN SCITECH CO., LTD. |
6840 SW 45TH LN | MIAMI | FL | 33155 |
| K213210 | LONGFIAN SCITECH CO., LTD. |
2F&3F, East Section, Building 12, Power Valley Pioneer Park, | Baoding | 071051 | |
| K080391 | MEDICAL DEPOT |
962 ALLEGRO LANE | APOLLO BEACH | FL | 33572 |
| K954506 | MEDTRAK INTL., INC. |
9841 BROKEN LAND PARKWAY, #107 | COLUMBIA | MD | 21046 |
| K050430 | MERITS HEALTH PRODUCTS CO., LTD. |
7690 CAMERON CIRCLE | FORT MYERS | FL | 33912 |
| K053229 | MERITS HEALTH PRODUCTS CO., LTD. |
9, ROAD 36 | TAICHUNG | 407 | |
| K053230 | MERITS HEALTH PRODUCTS CO., LTD. |
9, ROAD 36 | TAICHUNG | 407 | |
| K091716 | MERITS HEALTH PRODUCTS CO., LTD. |
9, ROAD 36 | TAICHUNG | 407 | |
| K014301 | MERITS HEALTH PRODUCTS CO., LTD. |
7690 CAMERON CIRCLE | FORT MYERS | FL | 33912 |
| K011844 | MERITS HEALTH PRODUCTS., INC. |
7690 CAMERON CIRCLE | FORT MYERS | FL | 33912 |
| K062153 | MOLECULAR PRODUCTS LTD. |
3460 POINTE CREEK CT. | BONITA SPRINGS | FL | 34134 |
| K131016 | MOLECULAR PRODUCTS LTD. |
24301 WOODSAGE DR. | BONITA SPRINGS | FL | 34134-2958 |
| K240561 | Molecular Products Ltd. |
Parkway | Harlow Essex | CM19 5FR | |
| K032509 | NIDEK MEDICAL PRODUCTS, INC. |
3949 VALLEY EAST INDUSTRIAL DR | BIRMINGHAM | AL | 35217 |
| K093308 | NIDEK MEDICAL PRODUCTS, INC. |
3949 VALLEY EAST INDUSTRIAL DR | BIRMINGHAM | AL | 35217 |
| K082566 | NIDEK MEDICAL PRODUCTS, INC. |
3949 VALLEY EAST INDUSTRIAL DR | BIRMINGHAM | AL | 35217 |
| K123738 | NIDEK MEDICAL PRODUCTS, INC. |
3949 VALLEY EAST INDUSTRIAL DR | BIRMINGHAM | AL | 35217 |
| K040892 | NIDEK MEDICAL PRODUCTS, INC. |
3949 VALLEY EAST INDUSTRIAL DR | BIRMINGHAM | AL | 35217 |
| K192693 | Nidek Medical Products, Inc. |
3949 Valley East Industrial Drive | Brimingham | AL | 35217 |
| K182454 | O2 Concepts LLC |
199 Park Road Extension | Middlebury | CT | 06762 |
| K020362 | ON SITE GAS SYSTEMS INC. |
35 BUDNEY RD. | NEWINGTON | CT | 06111 |
| K021082 | ON SITE GAS SYSTEMS, INC. |
35 BUDNEY RD. | NEWINGTON, | CT | 06111 |
| K014078 | ON SITE GAS SYSTEMS, INC. |
100 PRODUCTION COURT | NEW BRITAIN | CT | 06051 |
| K030920 | ON SITE GAS SYSTEMS, INC. |
35 BUDNEY RD. | NEWINGTON, | CT | 06111 |
| K063454 | ON SITE GAS SYSTEMS, INC. |
35 BUDNEY RD. | NEWINGTON | CT | 06111 |
| K092636 | ON SITE GAS SYSTEMS, INC. |
35 BUDNEY RD. | NEWINGTON | CT | 06111 |
| K041664 | ON SITE GAS SYSTEMS, INC. |
35 BUDNEY RD. | NEWINGTON, | CT | 06111 |
| K033863 | OX-GEN INC. |
PO BOX 5867 | BOISE | ID | 83702 |
| K060922 | OXLIFE LLC |
141 TWIN SPRINGS RD. | HENDERSONVILLE | NC | 28792 |
| K080082 | OXLIFE LLC |
141 TWIN SPRINGS RD. | HENDERSONVILLE | NC | 28792 |
| K971964 | OXLIFE, INC. |
917 15TH AVENUE S.E. | CAPE CORAL | FL | 33990 |
| K955549 | OXLIFE, INC. |
1432 VISCAYA PKWY. | CAPE CORAL | FL | 33990 |
| K162433 | OXUS, INC |
2676 PALDAN | AUBURN HILLS | MI | 48326 |
| K211056 | Oxus, Inc. |
2046 Brown Rd. | Auburn Hills | MI | 48326 |
| K052396 | OXYSURE SYSTEMS, INC. |
2611 INTERNET BLVD., SUITE 109 | FRISCO | TX | 75034 |
| K043615 | OXYTEC MEDICAL CORPORATION |
6329 W. WATERVIEW CT. | MCCORDSVILLE | IN | 46055-9501 |
| K020330 | PACIFIC CONSOLIDATED INDUSTRIES LLP |
3430 WEST CARRIAGE DR. | SANTA ANA | CA | 92704 |
| K040738 | PACIFIC CONSOLIDATED INDUSTRIES LLP |
3430 WEST CARRIAGE DR. | SANTA ANA | CA | 92704 |
| K100957 | PACIFIC CONSOLIDATED INDUSTRIES, LLC |
12201 MAGNOLIA AVE. | RIVERSIDE | CA | 92503 |
| K061414 | PACIFIC CONSOLIDATED INDUSTRIES, LLC |
12201 MAGNOLIA AVE. | RIVERSIDE | CA | 92503 |
| K120566 | PACIFIC PRECISION PRODUCTS |
9671 IRVINE CENTER DRIVE | IRVINE | CA | 92618 |
| K072348 | PRECISION MEDICAL, INC. |
300 HELD DR. | NORTHAMPTON | PA | 18067 |
| K103563 | PRECISION MEDICAL, INC. |
300 HELD DR. | NORTHAMPTON | PA | 18067 |
| K993088 | PURITAN BENNETT CORP. |
2200 FARADAY AVE. | CARLSBAD | CA | 92008 |
| K190304 | Qingdao Kingon Medical Science and Technology Co. |
24th East Building, No. 252 Yanhe Road, Tianhe Industrial | Qingdao | ||
| K242718 | Qingdao Kingon Medical Science and Technology Co., Ltd |
Room 301-302(B), No.15 Hancheng Road,Qingdao Free Trade Zone | Qingdao | 266510 | |
| K223379 | Qingdao Kingon Medical Science and Technology Co., Ltd. |
Room 301-302, No.15 HanchengRoad | Qingdao Free Trade Zone | 266555 | |
| K230702 | Qingdao Kingon Medical Science and Technology Co., Ltd. |
Room 301-302(B), No.15 HanchengRoad | Qingdao Free Trade Zone | 266555 | |
| K210371 | Qingdao Kingon Medical Science and Technology Co., Ltd. |
Room 301-302, No.15 HanchengRoad | Qingdao Free Trade Zone | 266555 | |
| K111885 | RESPIRONICS INC. |
1740 GOLDEN MILE HIGHWAY | MONROEVILLE | PA | 15146 |
| K091191 | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
1740 GOLDEN MILE HWY | MONROEVILLE | PA | 15146 |
| K081206 | RESPIRONICS, INC. |
1740 GOLDEN MILE HIGHWAY | MONROEVILLE | PA | 15146 |
| K061261 | RESPIRONICS, INC. |
1001 MURRY RIDGE LN. | MURRYSVILLE | PA | 15668 |
| K043006 | RESPIRONICS, INC. |
1001 MURRY RIDGE LN. | MURRYSVILLE | PA | 15668 |
| K091028 | RESPIRONICS, INC. |
1001 MURRY RIDGE LN. | MURRYSVILLE | PA | 15668 |
| K100920 | SEQUAL TECHNOLOGIES CO., LTD |
6F-7, NO.136, SEC. 3 | TAIPEI | 10657 | |
| K091541 | SEQUAL TECHNOLOGIES CO., LTD |
6F-7, NO.136, SEC. 3 | TAIPEI | 10657 | |
| K042262 | SEQUAL TECHNOLOGIES, INC. |
11436 SORRENTO VALLEY RD. | SAN DIEGO | CA | 92121-1393 |
| K003472 | SEQUAL TECHNOLOGIES, INC. |
11436 SORRENTO VALLEY RD. | SAN DIEGO | CA | 92121 |
| K083163 | SEQUAL TECHNOLOGIES, INC. |
11436 SORRENTO VALLEY RD. | SAN DIEGO | CA | 92121-1393 |
| K013931 | SEQUAL TECHNOLOGIES, INC. |
11436 SORRENTO VALLEY RD. | SAN DIEGO | CA | 92121-1393 |
| K081508 | SHENYANG CANTA MEDICAL TECH CO., LTD. |
SUITE 8D, NO. 19, LANE 999 | SHANGHAI | 200030 | |
| K971947 | SIM ITALIA S.R.L. |
55 NORTHERN BLVD., SUITE 410 | GREAT NECK | NY | 11021 |
| K963042 | SIM ITALIA S.R.L. |
55 NORTHERN BLVD., SUITE 410 | GREAT NECK | NY | 11021 |
| K030233 | SIM ITALIA S.R.L. |
55 NORTHERN BLVD., SUITE 200 | GREAT NECK | NY | 11021 |
| K952941 | SUN MEDICAL EQUIPMENT, INC. |
1825 S. DIVISION AVE. | ORLANDO | FL | 32806 |
| K071397 | SUNRISE MEDICAL |
100 DEVILBISS DR. | SOMERSET | PA | 15501 |
| K053240 | SUNRISE MEDICAL |
100 DEVILBISS DRIVE | SOMERSET | PA | 15501 |
| K081468 | SUNRISE MEDICAL |
100 DEVILBISS DR. | SOMERSET | PA | 15501 |
| K991722 | SUNRISE MEDICAL HHG, INC. |
100 DEVILBISS DR. | SOMERSET | PA | 15501 |
| K091650 | SWR INTERNATIONAL, LTD |
161 LITTLE BAY ROAD | NEWINGTON | NH | 03801 |
| K172234 | SysMed (China) Co., Ltd |
11-2-3 No. 17 Wensu Str., Hunnan New Dis. | Shenyang | 110171 | |
| K981078 | TRANSTRACHEAL SYSTEMS |
4655 KIRKWOOD COURT | BOULDER | CO | 80301 |
| K134023 | ULTRA ELECTRONICS LIMITED PRECISION AIR & LAND SY |
ARLE COURT | CHELTENHAM, GLOUCESTERSHIRE | GL51 6PN | |
| K121260 | VBOX, INC. |
2342 EAST COUNTY | WHITE BEAR LAKE | MN | 55110 |
| K033405 | ZHEJIANG LONGFEI INDUSTRIAL CO., LTD. |
2288 CAOYANG ROAD | SHANGHAI | 200333 | |
| K222920 | Zhengzhou Olive Electronic Technology Co., Ltd. |
5th Floor, Block D, Building 18, | Zhenghou | 450001 | |
| K121531 | ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. |
3 SHENGHUI SOUTH ROAD | GUANGDONG | ||
| K071608 | ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. |
3 SHENGHUI SOUTH ROAD | GUANGDONG |
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