EMT-CPAP

Ventilator, Emergency, Powered (resuscitator)

EMERGENCY MEDICAL TECHOLOGY

The following data is part of a premarket notification filed by Emergency Medical Techology with the FDA for Emt-cpap.

Pre-market Notification Details

Device IDK021520
510k NumberK021520
Device Name:EMT-CPAP
ClassificationVentilator, Emergency, Powered (resuscitator)
Applicant EMERGENCY MEDICAL TECHOLOGY 3722 AVE. SAUSALITO Irvine,  CA  92606
ContactGreg Holland
CorrespondentGreg Holland
EMERGENCY MEDICAL TECHOLOGY 3722 AVE. SAUSALITO Irvine,  CA  92606
Product CodeBTL  
CFR Regulation Number868.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-10
Decision Date2002-07-15

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