MATRX HOPE(R) 5 RESUSCITATOR

Ventilator, Emergency, Manual (resuscitator)

MATRIX MEDICA, INC.

The following data is part of a premarket notification filed by Matrix Medica, Inc. with the FDA for Matrx Hope(r) 5 Resuscitator.

Pre-market Notification Details

Device IDK921982
510k NumberK921982
Device Name:MATRX HOPE(R) 5 RESUSCITATOR
ClassificationVentilator, Emergency, Manual (resuscitator)
Applicant MATRIX MEDICA, INC. 145 MID COUNTY DR. Orchard Park,  NY 
ContactMichael Swart
CorrespondentMichael Swart
MATRIX MEDICA, INC. 145 MID COUNTY DR. Orchard Park,  NY 
Product CodeBTM  
CFR Regulation Number868.5915 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-04-28
Decision Date1994-10-28

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