FDA Product Code
FDA Product Code FMZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5400
510(k) Clearances — 86 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260326 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | Datex-Ohmeda, Inc. | 2026-07-28 | Traditional | PDF ↗ |
| K251619 | Babyleo TN500 | Drägerwerk AG & Co. KGaA | 2026-02-13 | Traditional | PDF ↗ |
| K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | Datex-Ohmeda, Inc. | 2025-10-22 | Traditional | PDF ↗ |
| K243437 | mOm Essential Incubator (ME1) | Mom Incubators Limited | 2025-08-14 | Traditional | PDF ↗ |
| K213553 | Giraffe Incubator Carestation CS1 | Datex Ohmeda, Inc. | 2022-03-02 | Traditional | PDF ↗ |
| K190494 | Infant Incubator | Ningbo David Medical Device Co., Ltd. | 2019-11-25 | Traditional | PDF ↗ |
| K182859 | Babyleo TN500 | Dragerwerk AG & CO Kgaa | 2019-02-22 | Special | PDF ↗ |
| K182977 | Isolette 8000 Plus | Draeger Medical Systems, Inc. | 2018-11-21 | Special | PDF ↗ |
| K172154 | Isolette 8000 plus | Draeger Medical Sytems, Inc. | 2018-04-19 | Traditional | PDF ↗ |
| K162821 | Babyleo TN500 | Draegerwerk AG & CO Kgaa | 2017-06-23 | Traditional | PDF ↗ |
| K152814 | Giraffe OmniBed Carestation CS1 | Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company | 2016-03-17 | Special | PDF ↗ |
| K152809 | Giraffe Incubator Carestation CS1 | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2015-12-31 | Special | PDF ↗ |
| K132543 | INFANT INCUBATOR | Bistos Co., Ltd. | 2014-07-03 | Traditional | PDF ↗ |
| K102226 | DUAL INCU I | Atom Medical Corporation | 2011-01-04 | Traditional | PDF ↗ |
| K102279 | INCU I | Atom Medical Corporation | 2010-12-29 | Traditional | PDF ↗ |
| K102710 | NEO-SERVO I | Atom Medical Corporation | 2010-12-22 | Traditional | PDF ↗ |
| K101788 | GIRAFFE OMNIBED | Ohmeda Medical | 2010-07-21 | Special | PDF ↗ |
| K101778 | GIRAFFE INCUBATOR | Ohmeda Medical | 2010-07-21 | Special | PDF ↗ |
| K071977 | TARRY MEDICAL TEMPERATURE PROBES | Tarry Medical Products, Inc. | 2008-05-23 | Traditional | PDF ↗ |
| K072512 | MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) | Datex-Ohmeda, Inc. | 2007-10-03 | Special | PDF ↗ |
| K070291 | MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX | Medix I.C.S.A. | 2007-09-21 | Traditional | PDF ↗ |
| K071175 | OHMEDA MEDICAL GIRAFFE OMNIBED | GE Healthcare | 2007-07-17 | Special | PDF ↗ |
| K061856 | V-2200 INFANT INCUBATOR | Atom Medical, Inc. | 2006-09-28 | Traditional | PDF ↗ |
| K053399 | VERSALET 7700 CARE CENTER | Draeger Medical Infant Care, Inc. | 2006-08-04 | Traditional | PDF ↗ |
| K061280 | V-2200 INFANT INCUBATOR | Neoforce Group, Inc. | 2006-06-27 | Traditional | PDF ↗ |
| K040910 | INFANT INCUBATOR, MODEL CHS-I1000 | Choong Wae Medical Corp. | 2004-04-21 | Traditional | PDF ↗ |
| K040068 | BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM | Ohmeda Medical | 2004-04-16 | Traditional | PDF ↗ |
| K031387 | ISOLETTE INFANT INCUBATOR, MODEL C2000E | Hill-Rom Manufacturing, Inc. | 2003-08-01 | Traditional | PDF ↗ |
| K021809 | V-2100G ADVANCED INFANT INCUBATOR | Atom Medical Corp | 2002-07-18 | Abbreviated | PDF ↗ |
| K020547 | OHMEDA MEDICAL GIRAFFE INCUBATOR | Ohmeda Medical | 2002-05-09 | Traditional | PDF ↗ |
| K020543 | OHMEDA MEDICAL GIRAFFE OMNIBED | Ohmeda Medical | 2002-05-09 | Traditional | PDF ↗ |
| K010222 | OHMEDA MEDICAL GIRAFFE INCUBATOR | Ohmeda Medical | 2001-03-21 | Traditional | PDF ↗ |
| K003067 | CALEO | Drager Medizintechnik GmbH | 2000-12-13 | Abbreviated | PDF ↗ |
| K001242 | ISOLETTE INFANT INCUBATOR, MODEL C2HS | Hill-Rom Air-Shields | 2000-07-13 | Traditional | PDF ↗ |
| K993051 | VERSALET 7700 CARE CENTER, MODEL # 7700 | Hill-Rom Air-Shields | 2000-02-03 | Traditional | PDF ↗ |
| K993407 | OHMEDA MEDICAL OMNIBED | Ohmeda Medical | 2000-01-05 | Traditional | PDF ↗ |
| K993712 | BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM | Ohmeda Medical | 1999-11-09 | Special | PDF ↗ |
| K980886 | BABYTHERM 8000 LDR | Draeger Medical, Inc. | 1998-05-29 | Traditional | PDF ↗ |
| K974349 | OHMEDA-OHIO CARE PLUS INCUBATOR | Ohmeda Medical | 1998-02-12 | Traditional | PDF ↗ |
| K954204 | DRAGER INCUBATOR 8000 IC | Drager, Inc. | 1997-04-25 | Traditional | PDF ↗ |
| K962806 | OHMEDA-OHIO CAE PLUS INCUBATOR | Ohmeda Medical | 1996-09-20 | Traditional | PDF ↗ |
| K960980 | ISOLETTE INFANT INCUBATOR | Air-Shields, Inc. | 1996-07-30 | Traditional | PDF ↗ |
| K943360 | OHIO CARE PLUS INCUBATOR | Ohmeda Medical | 1994-09-29 | Traditional | PDF ↗ |
| K940975 | C450/C400 INFANT INCUBATORS | Air-Shields, Inc. | 1994-06-23 | Traditional | PDF ↗ |
| K924324 | K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE | K-1 Medical Products, Inc. | 1993-11-12 | Traditional | PDF ↗ |
| K922618 | BOWRON | G.L. Bowron & Co. , Ltd. | 1993-08-19 | Traditional | PDF ↗ |
| K920049 | MEDIX PC-305 NEONATAL INCUBATOR | Medix I.C.S.A. | 1993-05-21 | Traditional | PDF ↗ |
| K924297 | DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER | Air-Shields Vickers, Inc. | 1993-03-18 | Traditional | PDF ↗ |
| K924170 | ISOLETTE INCUBATOR HUMIDITY METER | Air-Shields, Inc. | 1993-02-05 | Traditional | PDF ↗ |
| K912000 | TYPE INTERFACE 9271/1 INCUBATOR/WARMER | S & W Medico Teknik | 1992-09-21 | Traditional | PDF ↗ |
| K915752 | FIRST TOUCH/VILEDON NON-WOVEN FILTER | First Touch Disposables, Inc. | 1992-09-17 | Traditional | PDF ↗ |
| K914864 | MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR | Air-Shields, Inc. | 1992-03-13 | Traditional | PDF ↗ |
| K914487 | OHIO CARE PLUS INCUBATOR | Ohmeda Medical | 1991-12-18 | Traditional | PDF ↗ |
| K914134 | INCUBATOR 8000 SC | National Draeger, Inc. | 1991-11-22 | Traditional | PDF ↗ |
| K913394 | INCUBATOR 8000 IC | Dragerwerk AG | 1991-11-22 | Traditional | PDF ↗ |
| K913291 | MODEL C386 ISOLETTE(R) INFANT INCUBATOR | Air-Shields, Inc. | 1991-11-13 | Traditional | PDF ↗ |
| K912909 | SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM | Air-Shields Vickers, Inc. | 1991-11-05 | Traditional | PDF ↗ |
| K912910 | C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEM | Air-Shields Vickers, Inc. | 1991-10-30 | Traditional | PDF ↗ |
| K913154 | OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION | Ohmeda Medical | 1991-09-13 | Traditional | PDF ↗ |
| K901157 | MP4, MP4SI, IT4 INCUBATORS | Mediprema | 1991-03-27 | Traditional | PDF ↗ |
| K903378 | MODEL C286 ISOLETTE INFANT INCUBATOR | Air-Shields Vickers, Inc. | 1990-10-15 | Traditional | PDF ↗ |
| K900752 | INCUBATOR 8000 | Dragerwerk AG | 1990-08-02 | Traditional | PDF ↗ |
| K901585 | OHMEDA - OHIO(R) CARE PLUS INCUBATOR | Ohmeda Medical | 1990-06-22 | Traditional | PDF ↗ |
| K900735 | MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR | Preemicare Corp. | 1990-05-02 | Traditional | PDF ↗ |
| K895550 | K-1 INFANT TRANSPORT SYSTEM | K-1 Medical Products, Inc. | 1989-12-07 | Traditional | PDF ↗ |
| K895782 | NEONATAL INCUBATOR (ACCESSORY) | Air-Shields Vickers, Inc. | 1989-12-07 | Traditional | PDF ↗ |
| K890476 | ADEL - MODEL 986 INFANT WARMER | Adel Medical , Ltd. | 1989-06-16 | Traditional | PDF ↗ |
| K881476 | PREEMICARE MODEL D1-X1, SERIES 3000 | Preemicare Corp. | 1988-12-08 | Traditional | PDF ↗ |
| K884086 | C100 QT VARIABLE HEIGHT ADJUSTMENT INCUBATOR | Air-Shields Vickers, Inc. | 1988-11-14 | Traditional | PDF ↗ |
| K870223 | AMEDA AMELETTE(R) NEONATAL INCUBATOR | Hollister, Inc. | 1987-06-10 | Traditional | PDF ↗ |
| K870222 | AMEDA AMECARE(R) NEONATAL INCUBATOR | Hollister, Inc. | 1987-06-10 | Traditional | PDF ↗ |
| K871399 | OHIO(R) CARE PLUS INCUBATOR | Ohmeda Medical | 1987-06-05 | Traditional | PDF ↗ |
| K840526 | AMETHERM | Egnell, Inc. | 1984-04-30 | Traditional | PDF ↗ |
| K832418 | OHIO TEMPERATURE SIMULATOR | Airco/Ohio Medical Products | 1983-09-12 | Traditional | PDF ↗ |
| K822656 | C-200 INFANT INCUBATOR | Narco Scientific | 1982-10-18 | Traditional | PDF ↗ |
| K821896 | C-300 INFANT INCUBATOR | Narco Scientific | 1982-07-28 | Traditional | PDF ↗ |
| K813239 | OXYGENAIRE NURING INCUBATOR | Vickers America Medical Corp. | 1982-01-28 | Traditional | PDF ↗ |
| K813238 | NEOCARE BABY-CONTROLLED INCUBATOR | Vickers America Medical Corp. | 1982-01-22 | Traditional | PDF ↗ |
| K810792 | NEOCARE TEMPERATURE MONITOR | Vickers America Medical Corp. | 1981-04-29 | Traditional | PDF ↗ |
| K810067 | 140 NEOCARE AIR CONTROLLED INCUBATOR | Vickers America Medical Corp. | 1981-03-11 | Traditional | PDF ↗ |
| K802639 | OHIO IC INCUBATOR | Ohio Medical Products | 1980-11-12 | Traditional | PDF ↗ |
| K802640 | OHIO GC INCUBATOR | Ohio Medical Products | 1980-11-12 | Traditional | PDF ↗ |
| K802126 | ISOLETTE INCUBATOR C-100 | Narco Air-Shields | 1980-09-26 | Traditional | PDF ↗ |
| K801461 | THERMA-SHIELD | Olympic Medical Corp. | 1980-07-28 | Traditional | PDF ↗ |
| K781876 | ISOLETTE INCUBATOR | Air-Shields, Inc. | 1978-12-07 | Traditional | PDF ↗ |
| K780472 | INFANT INCUBATOR | Air-Shields, Inc. | 1978-04-19 | Traditional | PDF ↗ |
Product code FMZ · Class II · General Hospital. Data: openFDA.