RESUSCI INFLATE-A-SHIELD CPR BARRIER

Valve, Non-rebreathing

LAERDAL MEDICAL CORP.

The following data is part of a premarket notification filed by Laerdal Medical Corp. with the FDA for Resusci Inflate-a-shield Cpr Barrier.

Pre-market Notification Details

Device IDK001742
510k NumberK001742
Device Name:RESUSCI INFLATE-A-SHIELD CPR BARRIER
ClassificationValve, Non-rebreathing
Applicant LAERDAL MEDICAL CORP. 49 PLAIN ST. North Attleboro,  MA  02760
ContactCynthia J Nolte
CorrespondentCynthia J Nolte
LAERDAL MEDICAL CORP. 49 PLAIN ST. North Attleboro,  MA  02760
Product CodeCBP  
CFR Regulation Number868.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-06-08
Decision Date2000-10-06

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