FDA.reportPublic FDA data

510(k) K251619

Device
Babyleo TN500
Applicant
Drägerwerk AG & Co. KGaA
510(k) number
K251619
Product code
FMZ
Decision
Substantially Equivalent (SESE)
Decision date
2026-02-13
Date received
2025-05-27
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
No

Applicant Contact#

Contact
Lyubov Lange
Address
Moislinger Allee 53-55 Luebeck DE 23542 23542

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FMZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc.2025-10-22
K243437mOm Essential Incubator (ME1)Mom Incubators Limited2025-08-14
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