OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & 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 Single Use Adult, Child, Infant Manual Resuscitator With Mask & Reservoir.

Pre-market Notification Details

• Device ID: K021442
• 510k Number: K021442
• Device Name: OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR
• Classification: Ventilator, Emergency, Manual (resuscitator)
• Applicant: OEMEDIC INTERNATIONAL, INC. 13 RED FOX LN. Littleton, CO 80127
• Contact: Kevin Walls
• Correspondent: Kevin Walls; OEMEDIC INTERNATIONAL, INC. 13 RED FOX LN. Littleton, CO 80127
• Product Code: BTM
• CFR Regulation Number: 868.5915 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-05-06
• Decision Date: 2002-07-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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