MODULAIDE EMERG. CARDIAC LIFE SUPP. KT

Ventilator, Emergency, Manual (resuscitator)

LAERDAL MEDICAL CORP.

The following data is part of a premarket notification filed by Laerdal Medical Corp. with the FDA for Modulaide Emerg. Cardiac Life Supp. Kt.

Pre-market Notification Details

Device IDK822356
510k NumberK822356
Device Name:MODULAIDE EMERG. CARDIAC LIFE SUPP. KT
ClassificationVentilator, Emergency, Manual (resuscitator)
Applicant LAERDAL MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeBTM  
CFR Regulation Number868.5915 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-08-06
Decision Date1982-08-20

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