MANUAL RESUSCITATOR

Ventilator, Emergency, Manual (resuscitator)

VITAL SIGNS, INC.

The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Manual Resuscitator.

Pre-market Notification Details

Device IDK910856
510k NumberK910856
Device Name:MANUAL RESUSCITATOR
ClassificationVentilator, Emergency, Manual (resuscitator)
Applicant VITAL SIGNS, INC. 20 CAMPUS RD. Totowa,  NJ  07512
ContactAlborto Velez
CorrespondentAlborto Velez
VITAL SIGNS, INC. 20 CAMPUS RD. Totowa,  NJ  07512
Product CodeBTM  
CFR Regulation Number868.5915 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-02-28
Decision Date1991-06-18

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