OHIO CARE PLUS INCUBATOR

Incubator, Neonatal

OHMEDA MEDICAL

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

Pre-market Notification Details

Device IDK914487
510k NumberK914487
Device Name:OHIO CARE PLUS INCUBATOR
ClassificationIncubator, Neonatal
Applicant OHMEDA MEDICAL 9065 GUILFORD RD. Columbia,  MD  21046
ContactAlberto F Profumo
CorrespondentAlberto F Profumo
OHMEDA MEDICAL 9065 GUILFORD RD. Columbia,  MD  21046
Product CodeFMZ  
CFR Regulation Number880.5400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-08
Decision Date1991-12-18

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