GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM

Ventilator, Emergency, Powered (resuscitator)

OHMEDA MEDICAL

The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Giraffe And Panda T- Piece Resuscitation System.

Pre-market Notification Details

Device IDK070210
510k NumberK070210
Device Name:GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
ClassificationVentilator, Emergency, Powered (resuscitator)
Applicant OHMEDA MEDICAL 8880 GORMAN RD. Laurel,  MD  20723
ContactAgata Smieja
CorrespondentAgata Smieja
OHMEDA MEDICAL 8880 GORMAN RD. Laurel,  MD  20723
Product CodeBTL  
CFR Regulation Number868.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-22
Decision Date2007-04-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682100151 K070210 000

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