Birthing Room Warmer
FDA 510(k) K871594 · Air-Shields, Inc.
510(k) numberK871594
Submission
- Device name
- Birthing Room Warmer
- Applicant
- Air-Shields, Inc.
Hatboro, PA, US - Received
- April 24, 1987
- Decision date
- June 5, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FMT – Warmer, Infant Radiant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5130
- Specialty
- General Hospital
Other 510(k)s with product code FMT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243606 | Babyroo TN300FMT · Traditional | Draeger Medical Systems, Inc. | 01/17/2025SE |
| K230278 | Babyroo TN300FMT · Traditional | Draeger Medical Systems, Inc. | 05/30/2023SE |
| K213551 | Giraffe Omnibed Carestation CS1FMT · Traditional | Datex Ohmeda, Inc. | 03/02/2022SE |
| K201628 | Panda iRes Warmer, Giraffe WarmerFMT · Traditional | GE Healthcare | 02/12/2021SE |
| K200319 | HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface…FMT · Traditional | Deroyal Industries, Inc. | 04/02/2020SE |
| K191425 | Hydro-Temp Neonatal Skin Temperature Probe CoverFMT · Traditional | Deroyal Industries, Inc. | 01/21/2020SE |
| K173516 | NuBorne Infant WarmerFMT · Abbreviated | International Biomedical | 08/17/2018SE |
| K123309 | Giraffe and Panda WarmersFMT · Traditional | Ohmeda Medical | 02/05/2013SE |
| K120642 | Resuscitaire with AutobreathFMT · Traditional | Draeger Medical Systems, Inc. | 11/02/2012SE |
| K122267 | Giraffe and Panda WarmersFMT · Special | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 10/02/2012SE |
More from Ohmeda Medical, A Division of Datex-Ohmeda, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K974248 | Watchchild Obsterical Patient Data Management SystemHGM · Traditional | 10/07/1998SE |
| K972309 | JM-102 Jaundice MeterMQM · Traditional | 09/22/1998SE |
| K971256 | Duo-Lite Phototherapy SystemLBI · Traditional | 09/24/1997SE |
| K960980 | Isolette Infant IncubatorFMZ · Traditional | 07/30/1996SE |
| K924709 | Satcare Oxygen Controller/Monitor W/ Pulse OximeteKLK · Traditional | 01/17/1996SE |
| K940951 | RW Resucitaire Infant Radiant WarmerFMT · Traditional | 05/03/1995SE |
| K940975 | C450/C400 Infant IncubatorsFMZ · Traditional | 06/23/1994SE |
| K941106 | Model TI500 Isolette Infant IncubatorFPL · Traditional | 06/10/1994SE |
| K924170 | Isolette Incubator Humidity MeterFMZ · Traditional | 02/05/1993SE |
| K922150 | Examination LampKZF · Traditional | 07/21/1992SE |
Questions and answers
When was Birthing Room Warmer cleared by the FDA?
Birthing Room Warmer (K871594) received a 510(k) decision of Substantially Equivalent on June 5, 1987, 42 days after the submission was received.
What is the product code of K871594?
The FDA product code is FMT – Warmer, Infant Radiant, a Class II (moderate risk) device regulated under 21 CFR 880.5130.