TRANSPORT INCUBATOR

Incubator, Neonatal Transport

NARCO AIR-SHIELDS

The following data is part of a premarket notification filed by Narco Air-shields with the FDA for Transport Incubator.

Pre-market Notification Details

Device IDK790551
510k NumberK790551
Device Name:TRANSPORT INCUBATOR
ClassificationIncubator, Neonatal Transport
Applicant NARCO AIR-SHIELDS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFPL  
CFR Regulation Number880.5410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-03-20
Decision Date1979-04-24

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