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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, emergency, manual (resuscitator)
510(k) Number K881086
Device Name LIFEGUARD MOUTH TO MASK RESUSCITATOR
Applicant
LIFEGUARD MEDICAL PRODUCTS, INC.
7476 SHADELAND STATION WAY
INDIANAPOLIS,  IN  46256
Applicant Contact CRAIG TRIMBLE
Correspondent
LIFEGUARD MEDICAL PRODUCTS, INC.
7476 SHADELAND STATION WAY
INDIANAPOLIS,  IN  46256
Correspondent Contact CRAIG TRIMBLE
Regulation Number868.5915
Classification Product Code
BTM  
Date Received03/14/1988
Decision Date 04/14/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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