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510(k) K010222

Device
OHMEDA MEDICAL GIRAFFE INCUBATOR
Applicant
OHMEDA MEDICAL
510(k) number
K010222
Product code
FMZ  
Decision
Substantially Equivalent (SESE)
Decision date
2001-03-21
Date received
2001-01-24
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
ALBERTO F PROFUMO
Address
8880 Gorman Rd. Laurel MD US 20723 20723

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
K251619Babyleo TN500Drägerwerk AG & Co. KGaA2026-02-13
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

Legacy Summary#

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FDA Review#

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