FDA 510(k) Applications for Medical Device:
Unit, Neonatal Phototherapy
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K971256 | AIR-SHIELDS, INC. |
330 JACKSONVILLE RD. | HATBORO | PA | 19040 |
| K111547 | ATOM MEDICAL CORPORATION |
24301 WOODSAGE DRIVE | BONITA SPRINGS | FL | 34134 |
| K103828 | ATOM MEDICAL CORPORATION |
24301 WOODSAGE DRIVE | BONITA SPRINGS | FL | 34134 |
| K200031 | Avalon Biomedical (Shenzhen) Limited |
805 Building 4, Yinxing Zhijie, 1301-74, GuanGuang Road, | Longhua District | 518110 | |
| K142332 | Bio-Med USA |
27 New England Drive | Ramsey | NJ | 07446 |
| K210289 | Bistos Co., Ltd. |
7th Fl. A Bldg., Woolim Lions Valley 5-cha, 302, | Seongnam-si | 13201 | |
| K172656 | Draeger Medical Systems, Inc. |
3135 Quarry Road | Telford | PA | 18969 |
| K113206 | Draeger Medical Systems, Inc. |
3135 QUARRY RD. | TELFORD | PA | 18969 |
| K131196 | FANEM LDA |
18851 NE 29TH AVE 720 | AVENTURA | FL | 33180 |
| K002414 | FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE | EAST TAMAKI | ||
| K071828 | GE HEALTHCARE CLINICAL SYSTEMS |
8880 GORMAN ROAD | LAUREL | MD | 20723 |
| K090192 | INTERLECTRIC CORP. |
1401 LEXINGTON AVE. | WARREN | PA | 16365 |
| K160238 | INTERNATIONAL BIOMEDICAL |
8206 CROSS PARK DR. | AUSTIN | TX | 78754 |
| K040853 | INTERNATIONAL HOSPITAL SUPPLY CO. |
AMSTEL 320-1 | AMSTERDAM | 1017AP | |
| K190899 | Little Sparrows Technologies, Inc. |
176 Mystic Valley Parkway | Winchester | MA | 01890 |
| K053568 | LUMITEX, INC. |
8443 DOW CIR. | STRONGSVILLE | OH | 44136 |
| K120820 | LUMITEX, INC. |
8443 DOW CIR. | STRONGSVILLE | OH | 44136 |
| K962612 | MEDELA, INC. |
4610 PRIME PKWY. | MCHENRY | IL | 60050-7005 |
| K984589 | MEDELA, INC. |
4610 PRIME PKWY. | MCHENRY | IL | 60050-7005 |
| K010495 | MEDICAL ILLUMINATION INTERNATIONAL, INC. |
547 LIBRARY ST. | SAN FERNANDO | CA | 91340 |
| K072097 | MEDICAL SELECT, INC. |
120 SOUTHCENTER CT., SUITE 400 | MORRISVILLE | NC | 27560 |
| K103735 | MEDIX I.C.S.A. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071-3404 |
| K083179 | MEDIX I.C.S.A. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071 |
| K103589 | NATUS MEDICAL INCORPORATED |
5900 FIRST AVENUE SOUTH | SEATTLE | WA | 98108 |
| K182178 | Natus Medical Incorporated |
5900 First Avenue South | Seattle | WA | 98108 |
| K160745 | NATUS MEDICAL INCORPORATED |
5900 FIRST AVENUE SOUTH | SEATTLE | WA | 98108 |
| K160305 | Natus Medical Incorporated |
5900 First Avenue South | Seattle | WA | 98108 |
| K022196 | NATUS MEDICAL, INC. |
1501 INDUSTRIAL RD. | SAN CARLOS | CA | 94070 |
| K051869 | NATUS MEDICAL, INC. |
1501 INDUSTRIAL RD. | SAN CARLOS | CA | 94070 |
| K170585 | NeoLight, LLC |
1475 N Scottsdale Rd, Suite 200 | Scottsdale | AZ | 85257 |
| K163526 | NEOMEDLIGHT |
89-90 Rue Frederic FAYS | Villeurbanne | 69100 | |
| K011549 | OHMEDA MEDICAL |
8880 GORMAN RD. | LAUREL | MD | 20723 |
| K971601 | OLYMPIC MEDICAL CORP. |
5900 FIRST AVE., SOUTH | SEATTLE | WA | 98108 |
| K093618 | PHYSICIAN ENGINEERED PRODUCTS, INC. |
103 SMITH ST. | FRYEBURG | ME | 04037 |
| K110550 | PHYSICIAN ENGINEERED PRODUCTS, INC. |
103 SMITH ST. | FRYEBURG | ME | 04037 |
| K974830 | PHYSICIAN ENGINEERED PRODUCTS, INC. |
420 WEST SECOND ST. | PARK RAPIDS | MN | 56470 |
| K021531 | REPLACEMENT PARTS INDUSTRIES, INC. |
P.O. BOX 5019 | CHATSWORTH | CA | 91313-5019 |
| K070180 | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
1001 MURRY RIDGE LN. | MURRYSVILLE | PA | 15668 |
| K991627 | RESPIRONICS, INC. |
1501 ARDMORE BLVD. | PITTSBURGH | PA | 15221-4401 |
| K120168 | WIPRO GE HEALTHCARE PRIVATE, LTD. |
8880 GORMAN ROAD | LAUREL | MD | 20723 |
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