FDA 510(k) Applications for Medical Device:
Incubator, Neonatal
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K960980 | AIR-SHIELDS, INC. |
330 JACKSONVILLE RD. | HATBORO | PA | 19040 |
| K021809 | ATOM MEDICAL CORP. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K102226 | ATOM MEDICAL CORPORATION |
3-18-15 HONGO | BUNKYO-KU, TOKYO | 113-0033 | |
| K102279 | ATOM MEDICAL CORPORATION |
3-18-15 HONGO | BUNKYO-KU, TOKYO | 113-0033 | |
| K102710 | ATOM MEDICAL CORPORATION |
24301 WOODSTAGE DRIVE | BONITA SPRINGS | FL | 34134 |
| K061856 | ATOM MEDICAL INC |
35 COMMERCE DRIVE | IVYLAND | PA | 18974 |
| K132543 | BISTOS CO., LTD. |
27 NEW ENGLAND DRIVE | RAMSEY | NJ | 07446 |
| K040910 | CHOONGWAE MEDICAL CORP. |
1733 CANTON LANE | MARIETTA | GA | 30062 |
| K213553 | Datex Ohmeda Inc. |
9900 Innovation Drive | Wauwatosa | WI | 53226 |
| K072512 | DATEX-OHMEDA, INC. |
8880 GORMAN ROAD | LAUREL | MD | 20723 |
| K053399 | DRAEGER MEDICAL INFANT CARE, INC. |
330 JACKSONVILLE RD. | HATBORO | PA | 19040 |
| K182977 | Draeger Medical Systems, Inc. |
3135 Quarry Road | Telford | PA | 18969 |
| K172154 | Draeger Medical Sytems, Inc. |
3135 Quarry Road | Telford | PA | 18969 |
| K980886 | DRAEGER MEDICAL, INC. |
3135 QUARRY RD. | TELFORD | PA | 18969 |
| K162821 | Draegerwerk AG & Co. KGaA |
Moislinger Allee 53-55 | Luebeck | 23542 | |
| K003067 | DRAGER MEDIZINTECHNIK GMBH |
3136 QUARRY RD. | TELFORD | PA | 18969 |
| K954204 | DRAGER, INC. |
4101-100 PLEASANT VALLEY RD. | CHANTILLY | VA | 22021 |
| K182859 | Dragerwerk AG & Co. KGaA |
Moislinger Allee 53-55 | Lubeck | 23542 | |
| K071175 | GE HEALTHCARE |
8880 GORMAN RD | LAUREL | MD | 20723 |
| K001242 | HILL-ROM AIR-SHIELDS |
330 JACKSONVILLE RD. | HATBORO | PA | 19040 |
| K993051 | HILL-ROM AIR-SHIELDS |
330 JACKSONVILLE RD. | HATBORO | PA | 19040 |
| K031387 | HILL-ROM MANUFACTURING, INC. |
330 JACKSONVILLE RD. | HATBORO | PA | 19040 |
| K070291 | MEDIX I.C.S.A. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071 |
| K061280 | NEOFORCE GROUP, INC. |
5985 HONEY HOLLOW RD. | DOYLESTOWN | PA | 18901 |
| K190494 | Ningbo David Medical Device Co.,Ltd |
No.2, Keyuan Road, Shipu Technology Park, | Ningbo | 315731 | |
| K040068 | OHMEDA MEDICAL |
8880 GORMAN RD. | LAUREL | MD | 20723 |
| K993712 | OHMEDA MEDICAL |
9065 GUILFORD RD. | COLUMBIA | MD | 21046 |
| K101778 | OHMEDA MEDICAL |
8880 GORMAN RD. | LAUREL | MD | 20723 |
| K101788 | OHMEDA MEDICAL |
8880 GORMAN RD. | LAUREL | MD | 20723 |
| K010222 | OHMEDA MEDICAL |
8880 GORMAN RD. | LAUREL | MD | 20723 |
| K020547 | OHMEDA MEDICAL |
8880 GORMAN RD. | LAUREL | MD | 20723 |
| K020543 | OHMEDA MEDICAL |
8880 GORMAN RD. | LAUREL | MD | 20723 |
| K993407 | OHMEDA MEDICAL |
9065 GUILFORD RD. | COLUMBIA | MD | 21046 |
| K962806 | OHMEDA MEDICAL |
9065 GUILFORD RD. | COLUMBIA | MD | 21046 |
| K974349 | OHMEDA MEDICAL |
9065 GUILFORD RD. | COLUMBIA | MD | 21046 |
| K152809 | OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC. |
8880 GORMAN ROAD | LAUREL | MD | 20723 |
| K152814 | Ohmeda Medical, a Division of Datex-Ohmeda,Inc. A GE Company |
8880 Gorman Rooad | Laurel | MD | 20723 |
| K071977 | TARRY MEDICAL PRODUCTS, INC. |
543 LONG HILL AVENUE | SHELTON | CT | 06484 |
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