FDA.report

510(k) K243437

Device
mOm Essential Incubator (ME1)
Applicant
Mom Incubators Limited
510(k) number
K243437
Product code
FMZ
Decision
Substantially Equivalent (SESE)
Decision date
2025-08-14
Date received
2024-11-05
Regulation
880.5400
Classification name
Incubator, Neonatal
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Rosalyn Archer
Address
Newstead House Pelham Rd. Nottingham GB NG5 1AP NG5 1AP

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code FMZ

510(k)DeviceApplicantDecision date
K251619Babyleo TN500Drägerwerk AG & Co. KGaA2026-02-13
K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc.2025-10-22
K213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc.2022-03-02
K190494Infant IncubatorNingbo David Medical Device Co., Ltd.2019-11-25
K182859Babyleo TN500Dragerwerk AG & CO Kgaa2019-02-22
K182977Isolette 8000 PlusDraeger Medical Systems, Inc.2018-11-21
K172154Isolette 8000 plusDraeger Medical Sytems, Inc.2018-04-19
K162821Babyleo TN500Draegerwerk AG & CO Kgaa2017-06-23
K152814Giraffe OmniBed Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company2016-03-17
K152809Giraffe Incubator Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda, Inc.2015-12-31
K132543INFANT INCUBATORBistos Co., Ltd.2014-07-03
K102226DUAL INCU IAtom Medical Corporation2011-01-04
K102279INCU IAtom Medical Corporation2010-12-29
K102710NEO-SERVO IAtom Medical Corporation2010-12-22
K101778GIRAFFE INCUBATOROhmeda Medical2010-07-21