1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX

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 Manual Resuscitator, Model 85xx.

Pre-market Notification Details

Device IDK014115
510k NumberK014115
Device Name:1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX
ClassificationVentilator, Emergency, Manual (resuscitator)
Applicant PORTEX, INC. 10 BOWMAN DR. Keene,  NH  03431
ContactTimothy J Talcott
CorrespondentTimothy J Talcott
PORTEX, INC. 10 BOWMAN DR. Keene,  NH  03431
Product CodeBTM  
CFR Regulation Number868.5915 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-12-14
Decision Date2002-02-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
35019315060940 K014115 000
35019315060902 K014115 000
35019315060896 K014115 000
35019315052501 K014115 000
35019315049488 K014115 000
30351688431541 K014115 000

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