FDA 510(k) Applications for Medical Device:
Warmer, Infant Radiant
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K002355 | ATOM MEDICAL CORP. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K102227 | ATOM MEDICAL CORPORATION |
3-18-15 HONGO | BUNKYO-KU, TOKYO | 113-0033 | |
| K120937 | ATOM MEDICAL CORPORATION |
24301 WOODSAGE DRIVE | BONITA SPRINGS | FL | 34134 |
| K060461 | ATOM MEDICAL INC |
IWAKATA BLDG 3RD FLOOR | TOKOYO | 1130033 | |
| K952800 | CONTOUR MEDICAL TECHNOLOGY, INC. |
144 SOUTHWAY BLVD. | LAVERGNE | TN | 37086 |
| K952801 | CONTOUR MEDICAL TECHNOLOGY, INC. |
144 SOUTHWAY BLVD. | LAVERGNE | TN | 37086 |
| K952803 | CONTOUR MEDICAL TECHNOLOGY, INC. |
144 SOUTHWAY BLVD. | LAVERGNE | TN | 37086 |
| K952804 | CONTOUR MEDICAL TECHNOLOGY, INC. |
144 SOUTHWAY BLVD. | LAVERGNE | TN | 37086 |
| K952805 | CONTOUR MEDICAL TECHNOLOGY, INC. |
144 SOUTHWAY BLVD. | LAVERGNE | TN | 37086 |
| K952807 | CONTOUR MEDICAL TECHNOLOGY, INC. |
144 SOUTHWAY BLVD. | LAVERGNE | TN | 37086 |
| K213551 | Datex Ohmeda Inc. |
9900 Innovation Drive | Wauwatosa | WI | 53226 |
| K200319 | DeRoyal Industries, Inc. |
200 DeBusk Lane | Powell | TN | 37849 |
| K191425 | DeRoyal Industries, Inc. |
200 DeBusk Lane | Powell | TN | 37849 |
| K230278 | Draeger Medical Systems, Inc. |
3135 Quarry Road | Telford | PA | 18969 |
| K120642 | Draeger Medical Systems, Inc. |
3135 QUARRY RD. | TELFORD | PA | 18969 |
| K971198 | DRAGER, INC. |
4101 PLEASENT VALLEY ROAD, | CHANTILLY | VA | 22021 |
| K953489 | DRAGER, INC. |
4101-100 PLEASANT VALLEY RD. | CHANTILLY | VA | 22021 |
| K950422 | FIRST TOUCH DISPOSABLES, INC. |
3342 WRIGHTVILLE AVE. | WILMINGTON | NC | 28403 |
| K970432 | FISHER & PAYKEL ELECTRONICS LTD. |
HEALTHCARE DIV. | AUCKLAND | ||
| K971695 | FISHER & PAYKEL ELECTRONICS LTD. |
25 CARBINE RD. | AUCKLAND | ||
| K972885 | FISHER & PAYKEL ELECTRONICS LTD. |
HEALTHCARE DIV. | AUCKLAND | ||
| K971461 | FISHER & PAYKEL ELECTRONICS LTD. |
HEALTHCARE DIV. | AUCKLAND | ||
| K201628 | GE Healthcare |
9900 Innovation Drive | Wauwatosa | WI | 53226 |
| K003335 | HILL-ROM AIR-SHIELDS |
330 JACKSONVILLE RD. | HATBORO | PA | 19040 |
| K971366 | HILL-ROM, INC. |
1069 STATE ROUTE 46 EAST | BATESVILLE | IN | 47006 |
| K970074 | HILL-ROM, INC. |
1069 STATE ROUTE 46 EAST | BATESVILLE | IN | 47006 |
| K173516 | International Biomedical |
8206 Cross Park Drive | Austin | TX | 78754 |
| K033040 | INTERNATIONAL HOSPITAL SUPPLY CO. |
AMSTEL 320-1 | AMSTERDAM | 1017AP | |
| K960080 | KENTEC MEDICAL, INC. |
17871 FITCH | IRVINE | CA | 92614-6001 |
| K970686 | KENTEC MEDICAL, INC. |
17871 FITCH | IRVINE | CA | 92614-6001 |
| K964401 | LUDLOW TECHNICAL PRODUCTS |
TWO LUDLOW PARK | CHICOPEE | MA | 01022 |
| K012229 | NATIONAL CUSTOM ENT., INC. |
1133 EAST CLIFF RD. | BURNSVILLE | MN | 55337 |
| K070377 | OHMEDA MEDICAL |
8880 GORMAN RD. | LAUREL | MD | 20723 |
| K123309 | OHMEDA MEDICAL |
8880 GORMAN RD. | LAUREL | MD | 20723 |
| K963058 | OHMEDA MEDICAL |
9065 GUILFORD RD. | COLUMBIA | MD | 21046 |
| K072157 | OHMEDA MEDICAL |
8880 GORMAN RD. | LAUREL | MD | 20723 |
| K090697 | OHMEDA MEDICAL |
8880 GORMAN RD. | LAUREL | MD | 20723 |
| K101804 | OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC., |
8880 GORMAN RD. | LAUREL | MD | 20723 |
| K122267 | OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC., |
8880 GORMAN RD. | LAUREL | MD | 20723 |
| K020966 | REPLACEMENT PARTS INDUSTRIES, INC. |
P.O. BOX 5019 | CHATSWORTH | CA | 91313-5019 |
| K020219 | REPLACEMENT PARTS INDUSTRIES, INC. |
P.O. BOX 5019 | CHATSWORTH | CA | 91313-5019 |
| K121625 | WIPRO GE HEALTHCARE PRIVATE, LTD. |
8880 GOMAN ROAD | LAUREL | MD | 20723-5800 |
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