DMR PLUS DISPOSABLE MANUAL RESUSCITATOR

Ventilator, Emergency, Manual (resuscitator)

NELLCOR PURITAN BENNETT, INC.

The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Dmr Plus Disposable Manual Resuscitator.

Pre-market Notification Details

Device IDK973419
510k NumberK973419
Device Name:DMR PLUS DISPOSABLE MANUAL RESUSCITATOR
ClassificationVentilator, Emergency, Manual (resuscitator)
Applicant NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton,  CA  94588 -2719
ContactSheryll A Mathews
CorrespondentSheryll A Mathews
NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton,  CA  94588 -2719
Product CodeBTM  
CFR Regulation Number868.5915 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-10
Decision Date1998-03-25
Summary:summary

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