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 | Jan 17, 2025 |
| K230278 | Draeger Medical Systems | Babyroo TN300 | May 30, 2023 |
| K213551 | Datex Ohmeda | Giraffe Omnibed Carestation CS1 | Mar 2, 2022 |
| K201628 | Ge Healthcare | Panda iRes Warmer, Giraffe Warmer | Feb 12, 2021 |
| K200319 | Deroyal Industries | HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Su | Apr 2, 2020 |
| K191425 | Deroyal Industries | Hydro-Temp Neonatal Skin Temperature Probe Cover | Jan 21, 2020 |
| K173516 | International Biomedical | NuBorne Infant Warmer | Aug 17, 2018 |
| K123309 | Ohmeda Medical | GIRAFFE AND PANDA WARMERS | Feb 5, 2013 |
| K120642 | Draeger Medical Systems | RESUSCITAIRE WITH AUTOBREATH | Nov 2, 2012 |
| K122267 | Ohmeda Medical, A Division Of Datex-Ohmeda | GIRAFFE AND PANDA WARMERS | Oct 2, 2012 |
| K121625 | Wipro Ge Healthcare Private | LULLABY TM WARMER | Sep 14, 2012 |
| K120937 | Atom Medical Corporation | SUNFLOWER WARNER | Jul 6, 2012 |
| K102227 | Atom Medical Corporation | INFA WARMER I | Jan 21, 2011 |
| K101804 | Ohmeda Medical, A Division Of Datex-Ohmeda | GIRAFFE AND PANDA WARMERS | Jul 21, 2010 |
| K090697 | Ohmeda Medical | MODIFICATION TO: GIRAFFE AND PANDA WARMER | Apr 16, 2009 |
| K072157 | Ohmeda Medical | MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POW | Aug 27, 2007 |
| K070377 | Ohmeda Medical | GIRAFFE AND PANDA WARMER | Jul 11, 2007 |
| K060461 | Atom Medical | V-505 INFA WARMER | Apr 28, 2006 |
| K033040 | International Hospital Supply | PHOENIX INFANT RADIANT WARMER, MODEL 100NWS | Dec 17, 2003 |
| K020966 | Replacement Parts Industries | RPI REPLACEMENT HEATING ELEMENTS | Jun 13, 2002 |