1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE

Ventilator, Emergency, Manual (resuscitator)

SIMS PORTEX, INC.

The following data is part of a premarket notification filed by Sims Portex, Inc. with the FDA for 1st Response Infant Manual Resuscitator, Bag Resevoir, 1st Response Pediatric Manual Resuscitator, Bag Reservoir, 1st Re.

Pre-market Notification Details

Device IDK991861
510k NumberK991861
Device Name:1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE
ClassificationVentilator, Emergency, Manual (resuscitator)
Applicant SIMS PORTEX, INC. 10 BOWMAN DR. Keene,  NH  03431
ContactTimothy J Talcott
CorrespondentTimothy J Talcott
SIMS PORTEX, INC. 10 BOWMAN DR. Keene,  NH  03431
Product CodeBTM  
CFR Regulation Number868.5915 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-06-01
Decision Date2000-01-18
Summary:summary

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