OHMEDA AUXILIARY POWER SYSTEM

Warmer, Infant Radiant

OHMEDA MEDICAL

The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda Auxiliary Power System.

Pre-market Notification Details

Device IDK863208
510k NumberK863208
Device Name:OHMEDA AUXILIARY POWER 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 Received1986-08-19
Decision Date1986-10-03

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