DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE

Ventilator, Emergency, Manual (resuscitator)

GALEMED CORP.

The following data is part of a premarket notification filed by Galemed Corp. with the FDA for Dispo-bag Manual Resuscitator, Disposable Adjustable Peep Valve, Disposable Fixed Peep Valve.

Pre-market Notification Details

Device IDK082092
510k NumberK082092
Device Name:DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE
ClassificationVentilator, Emergency, Manual (resuscitator)
Applicant GALEMED CORP. 54431 AVENIDA ENCINAS SUITE G Carlsbad,  CA  90228 -4411
ContactThomas Loescher
CorrespondentThomas Loescher
GALEMED CORP. 54431 AVENIDA ENCINAS SUITE G Carlsbad,  CA  90228 -4411
Product CodeBTM  
CFR Regulation Number868.5915 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-07-24
Decision Date2008-10-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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44710810084902 K082092 000

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