OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR

Ventilator, Emergency, Manual (resuscitator)

OEMEDIC INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Oemedic International, Inc. with the FDA for Oemedic International Inc. Besmed Silicone Adult, Child, Infant Manual Resuscitator With Mask And Reservoir.

Pre-market Notification Details

Device IDK021446
510k NumberK021446
Device Name:OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR
ClassificationVentilator, Emergency, Manual (resuscitator)
Applicant OEMEDIC INTERNATIONAL, INC. 13 RED FOX LN. Littleton,  CO  80127
ContactKevin Walls
CorrespondentKevin Walls
OEMEDIC INTERNATIONAL, INC. 13 RED FOX LN. Littleton,  CO  80127
Product CodeBTM  
CFR Regulation Number868.5915 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-06
Decision Date2002-10-11
Summary:summary

NIH GUDID Devices

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