FDA 510(k) Applications for Medical Device:
Meter, Peak Flow, Spirometry
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K961779 | AVION MEDICAL PRODUCTS, INC. |
4361 HARVESTER RD., UNIT 1 | BURLINGTON, ONTARIO | L7L 5M4 | |
| K170281 | Beijing M&B Electronic Instruments Co., Ltd. |
No. 27, Yongwang Road, Daxing Bioengineering and Medicine | Beijing | 101102 | |
| K133975 | BEIJING M&B ELECTRONIC INSTRUMENTS, CO., LTD |
7TH FLOOR, JINGUI BUSINESS BUILDING, NO.982 CONGYUN RD | GUANGZHOU, GUANGDONG | 510420 | |
| K172804 | Besmed Health Business Corp. |
No.5, Lane 116, Wu-Kong 2nd Rd | Wu-Ku District | ||
| K180487 | Breathe me LTD |
13 Zarchin street | Ra'anana | 4366241 | |
| K050853 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. | REHOVOT | 76100 | |
| K954277 | CENTER LABORATORIES, INC. |
35 CHANNEL DR. | PORT WASHINGTON | NY | 11050 |
| K241338 | Chongqing Moffy Innovation Technology Co.,Ltd. |
No.292 Jingdongfang Rd.Beibei Dist | Chongqing | 400714 | |
| K982334 | CLEMENT CLARKE INTL., LTD. |
EDINBURGH WAY | HARLOW | CM20 2TT | |
| K980960 | CLEMENT CLARKE INTL., LTD. |
EDINBURGH WAY | HARLOW | CM20 2TT | |
| K053156 | CLEMENT CLARKE INTL., LTD. |
EDINBURGH WAY | HARLOW, ESSEX | CM20 2TT | |
| K962074 | CLEMENT CLARKE INTL., LTD. |
EDINBURGH WAY | HARLOW | CM20 2TT | |
| K952713 | CLEMENT CLARKE, INC. |
AIRMED HOUSE, EDINBURGH WAY | ENGLAND | ||
| K082899 | DYNAMITECH MEDICAL, INC |
PACIFIC NORTHWEST BRANCK | GRANTS PASS | OR | 97526 |
| K982676 | ENACT HEALTH MANAGEMENT SYSTEMS |
1975 EL CAMINO REAL WEST, #306 | MOUNTAIN VIEW | CA | 94040-2218 |
| K982675 | ENACT HEALTH MANAGEMENT SYSTEMS |
1975 EL CAMINO REAL WEST, #306 | MOUNTAIN VIEW | CA | 94040-2218 |
| K022124 | GALEMED CORP. |
87, LI-GONG 2ND RD., | WU-JIA, I-LAN | 268 | |
| K222810 | GOSTAR Co., Ltd. |
2F, No.65, Wuquan 7nd Rd. | New Taipei City | 248020 | |
| K191239 | Guangzhou Homesun Medical Technology Co., Ltd |
Floor 7th, TianxiangBusiness Building, | Guangzhou | 510250 | |
| K992618 | HARWILL MEDICAL (PTY) LTD. |
P O BOX 4341 | CROFTON | MD | 21114 |
| K980550 | HARWILL MEDICAL (PTY) LTD. |
P O BOX 4341 | CROFTON | MD | 21114 |
| K962929 | HEALTHSCAN PRODUCTS, INC. |
908 POMPTON AVE. | CEDAR GROVE | NJ | 07009-1292 |
| K962924 | HEALTHSCAN PRODUCTS, INC. |
908 POMPTON AVE. | CEDAR GROVE | NJ | 07009-1292 |
| K952909 | HEALTHSCAN, INC. |
908 POMPTON AVE. | CEDAR GROVE | NJ | 07009-1292 |
| K970507 | INTL. MEDICAL, INC. |
14470 BURNSVILLE PKWY. | BURNSVILLE | MN | 55306 |
| K092335 | K-JUMP HEALTH CO., LTD. |
NO. 56, WU KUNG 5TH RD., | TAIPEI HSIEN | 248 | |
| K232588 | Knox Medical Diagnostics |
650 California Street, FL 7 | San Francisco | CA | 94108 |
| K193311 | Knox Medical Diagnostics, Inc. |
345 California Street, Suite 600 | San Francisco | CA | 94104 |
| K982995 | KORR MEDICAL TECHNOLOGIES, INC. |
3090 EAST 3300 SOUIH #3B | SALT LAKE CITY | UT | 84109-2106 |
| K030586 | MICRO DIRECT, INC. |
803 WEBSTER ST. | LEWISTON | ME | 04240 |
| K031024 | MICROLIFE CORP. |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K040723 | MICROLIFE INTELLECTUAL PROPERTY GMBH |
55 NORTHERN BLVD., SUITE 200 | GREAT NECK | NY | 11021 |
| K181666 | MIR Medical International Research |
Via del Maggiolino, 125 | Roma | 00155 | |
| K964130 | MONAGHAN MEDICAL CORP. |
5 LATOUR AVE., SUITE 1600 | PLATTSBURGH | NY | 12901 |
| K031514 | MONAGHAN MEDICAL CORP. |
5 LATOUR AVE., SUITE 1600 | PLATTSBURGH | NY | 12901 |
| K991212 | MONAGHAN MEDICAL CORP. |
5 LATOUR AVE., SUITE 1600 | PLATTSBURGH | NY | 12901 |
| K123945 | MONAGHAN MEDICAL CORP. |
5 LATOUR AVE., SUITE 1600 | PLATTSBURGH | NY | 12901 |
| K023097 | MONAGHAN MEDICAL CORP. |
5 LATOUR AVE., SUITE 1600 | PLATTSBURGH | NY | 12901 |
| K955234 | MONAGHAN MEDICAL CORP. |
5 LATOUR AVE., SUITE 1600 | PLATTSBURGH | NY | 12901 |
| K963095 | MONAGHAN MEDICAL CORP. |
5 LATOUR AVE., SUITE 1600 | PLATTSBURGH | NY | 12901 |
| K955262 | MONAGHAN MEDICAL CORP. |
5 LATOUR AVE., SUITE 1600 | PLATTSBURGH | NY | 12901 |
| K963089 | MONAGHAN MEDICAL CORP. |
5 LATOUR AVE., SUITE 1600 | PLATTSBURGH | NY | 12901 |
| K101380 | NOBLE MARKETING |
11460 N. MERIDIAN ST. | CARMEL | IN | 46032 |
| K010009 | PDS HEALTHCARE PRODUCTS, INC. |
908 MAIN ST. | LOUISVILE | CO | 80027 |
| K013489 | PDS HEALTHCARE PRODUCTS, INC. |
908 MAIN ST. | LOUISVILLE | CO | 80027 |
| K953411 | ROXON - UNIVERSAL MEDICAL LTD. |
141, EAST - COLUMBIA ST. | NEW WESTMINISTER, B.C. | V3L 3V9 | |
| K200832 | Safey Medical Devices Pvt Ltd |
3rd Floor, Office 303, Nyati Emporius, S no 105 H no 4A, | Pune | 411045 | |
| K203196 | Shanghai Sonmol Medical Equipment Co., Ltd. |
Room 116-118, Building 21,No.500 Jiajian Road, | Shanghai | ||
| K152276 | Sparo Inc. |
911 Washington Ave, #809 | Saint Louis | MO | 63101 |
| K980951 | STI MEDICAL |
908 POMPTON AVE. | CEDAR GROVE | NJ | 07009 |
| K230423 | Taian Dalu Medical Instrument Co., Ltd. |
West Part of Yitianmen Street, Hi-tech Zone | Taian | 271000 | |
| K980443 | THE D&T, INC. |
86 BEDFORD AVE. | HAMDEN | CT | 06517 |
| K091412 | VIASYS HEALTHCARE GMBH |
LEIBNIZSTRASSE 7 | HOECHBERG | 97204 | |
| K991412 | VITALOGRAPH, INC. |
8347 QUIVIRA RD. | LENEXA | KS | 66215 |
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