GIRAFFE INCUBATOR

Incubator, Neonatal

OHMEDA MEDICAL

The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Giraffe Incubator.

Pre-market Notification Details

Device IDK101778
510k NumberK101778
Device Name:GIRAFFE INCUBATOR
ClassificationIncubator, Neonatal
Applicant OHMEDA MEDICAL 8880 GORMAN RD. Laurel,  MD  20723
ContactAgata Smieja
CorrespondentAgata Smieja
OHMEDA MEDICAL 8880 GORMAN RD. Laurel,  MD  20723
Product CodeFMZ  
CFR Regulation Number880.5400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-06-25
Decision Date2010-07-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682110808 K101778 000

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