OHMEDA 5000 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 Ohmeda 5000 Infant Warmer System.

Pre-market Notification Details

Device IDK851449
510k NumberK851449
Device Name:OHMEDA 5000 INFANT WARMER SYSTEM
ClassificationWarmer, Infant Radiant
Applicant OHMEDA MEDICAL OHMEDA DRIVE, P.O. BOX 7550 Madison,  WI  53707 -7550
ContactRaymond T Riddle
CorrespondentRaymond T Riddle
OHMEDA MEDICAL OHMEDA DRIVE, P.O. BOX 7550 Madison,  WI  53707 -7550
Product CodeFMT  
CFR Regulation Number880.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-04-11
Decision Date1985-06-07

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