FMZ — Incubator, Neonatal Class II
FDA Device Classification
Classification Details
- Product Code
- FMZ
- Device Class
- Class II
- Regulation Number
- 880.5400
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K251619 | drägerwerk ag and co kgaa | Babyleo TN500 | February 13, 2026 |
| K251663 | datex-ohmeda | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | October 22, 2025 |
| K243437 | mom incubators limited | mOm Essential Incubator (ME1) | August 14, 2025 |
| K213553 | datex ohmeda | Giraffe Incubator Carestation CS1 | March 2, 2022 |
| K190494 | ningbo david medical device co | Infant Incubator | November 25, 2019 |
| K182859 | dragerwerk ag and co kgaa | Babyleo TN500 | February 22, 2019 |
| K182977 | draeger medical systems | Isolette 8000 Plus | November 21, 2018 |
| K172154 | draeger medical sytems | Isolette 8000 plus | April 19, 2018 |
| K162821 | draegerwerk ag and co kgaa | Babyleo TN500 | June 23, 2017 |
| K152814 | ohmeda medical, a division of datex-ohmeda,inc. a ge | Giraffe OmniBed Carestation CS1 | March 17, 2016 |
| K152809 | ohmeda medical, a division of datex-ohmeda | Giraffe Incubator Carestation CS1 | December 31, 2015 |
| K132543 | bistos co | INFANT INCUBATOR | July 3, 2014 |
| K102226 | atom medical corporation | DUAL INCU I | January 4, 2011 |
| K102279 | atom medical corporation | INCU I | December 29, 2010 |
| K102710 | atom medical corporation | NEO-SERVO I | December 22, 2010 |
| K101788 | ohmeda medical | GIRAFFE OMNIBED | July 21, 2010 |
| K101778 | ohmeda medical | GIRAFFE INCUBATOR | July 21, 2010 |
| K071977 | tarry medical products | TARRY MEDICAL TEMPERATURE PROBES | May 23, 2008 |
| K072512 | datex-ohmeda | MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPT | October 3, 2007 |
| K070291 | medix i.c | MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX | September 21, 2007 |