FMT — Warmer, Infant Radiant Class II
FDA product code FMT covers "Warmer, Infant Radiant", a Class II medical device regulated under 21 CFR 880.5130. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FMT
- Device Class
- Class II
- Regulation Number
- 880.5130
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243606 | draeger medical systems | Babyroo TN300 | January 17, 2025 |
| K230278 | draeger medical systems | Babyroo TN300 | May 30, 2023 |
| K213551 | datex ohmeda | Giraffe Omnibed Carestation CS1 | March 2, 2022 |
| K201628 | ge healthcare | Panda iRes Warmer, Giraffe Warmer | February 12, 2021 |
| K200319 | deroyal industries | HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Su | April 2, 2020 |
| K191425 | deroyal industries | Hydro-Temp Neonatal Skin Temperature Probe Cover | January 21, 2020 |
| K173516 | international biomedical | NuBorne Infant Warmer | August 17, 2018 |
| K123309 | ohmeda medical | GIRAFFE AND PANDA WARMERS | February 5, 2013 |
| K120642 | draeger medical systems | RESUSCITAIRE WITH AUTOBREATH | November 2, 2012 |
| K122267 | ohmeda medical, a division of datex-ohmeda | GIRAFFE AND PANDA WARMERS | October 2, 2012 |
| K121625 | wipro ge healthcare private | LULLABY TM WARMER | September 14, 2012 |
| K120937 | atom medical corporation | SUNFLOWER WARNER | July 6, 2012 |
| K102227 | atom medical corporation | INFA WARMER I | January 21, 2011 |
| K101804 | ohmeda medical, a division of datex-ohmeda | GIRAFFE AND PANDA WARMERS | July 21, 2010 |
| K090697 | ohmeda medical | MODIFICATION TO: GIRAFFE AND PANDA WARMER | April 16, 2009 |
| K072157 | ohmeda medical | MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POW | August 27, 2007 |
| K070377 | ohmeda medical | GIRAFFE AND PANDA WARMER | July 11, 2007 |
| K060461 | atom medical | V-505 INFA WARMER | April 28, 2006 |
| K033040 | international hospital supply | PHOENIX INFANT RADIANT WARMER, MODEL 100NWS | December 17, 2003 |
| K020966 | replacement parts industries | RPI REPLACEMENT HEATING ELEMENTS | June 13, 2002 |