INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUS

Warmer, Infant Radiant

AIR-SHIELDS, INC.

The following data is part of a premarket notification filed by Air-shields, Inc. with the FDA for Infant Intensive Care System Vertical Height Adjus.

Pre-market Notification Details

Device IDK875270
510k NumberK875270
Device Name:INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUS
ClassificationWarmer, Infant Radiant
Applicant AIR-SHIELDS, INC. 330 JACKSONVILLE RD. Hatboro,  PA  19040
ContactFrancis X Casey
CorrespondentFrancis X Casey
AIR-SHIELDS, INC. 330 JACKSONVILLE RD. Hatboro,  PA  19040
Product CodeFMT  
CFR Regulation Number880.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-12-22
Decision Date1988-01-19

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