1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR

Ventilator, Emergency, Manual (resuscitator)

PORTEX, INC.

The following data is part of a premarket notification filed by Portex, Inc. with the FDA for 1st Response Intermediate Manual Resuscitator.

Pre-market Notification Details

Device IDK023793
510k NumberK023793
Device Name:1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR
ClassificationVentilator, Emergency, Manual (resuscitator)
Applicant PORTEX, INC. 10 BOWMAN DR. Keene,  NH  03431
ContactCindy Engelhardt
CorrespondentCindy Engelhardt
PORTEX, INC. 10 BOWMAN DR. Keene,  NH  03431
Product CodeBTM  
CFR Regulation Number868.5915 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-11-13
Decision Date2003-02-11
Summary:summary

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