OHIO INFANT WARMER SYSTEM

Warmer, Infant Radiant

OHMEDA MEDICAL

The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohio Infant Warmer System.

Pre-market Notification Details

Device IDK921766
510k NumberK921766
Device Name:OHIO INFANT WARMER SYSTEM
ClassificationWarmer, Infant Radiant
Applicant OHMEDA MEDICAL 9065 GUILFORD RD. Columbia,  MD  21046
ContactAlberto F Profumo
CorrespondentAlberto F Profumo
OHMEDA MEDICAL 9065 GUILFORD RD. Columbia,  MD  21046
Product CodeFMT  
CFR Regulation Number880.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-04-14
Decision Date1993-04-23

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