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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 K873043
Device Name MOUTH TO FACE RESUSCITATOR
Applicant
ARTEC ENVIRONMENTAL MONITORING DIVISION
P.O. BOX 68
NOBLESVILLE,  IN  46060
Applicant Contact TIMOTHY D STRUTHERS
Correspondent
ARTEC ENVIRONMENTAL MONITORING DIVISION
P.O. BOX 68
NOBLESVILLE,  IN  46060
Correspondent Contact TIMOTHY D STRUTHERS
Regulation Number868.5915
Classification Product Code
BTM  
Date Received08/04/1987
Decision Date 09/28/1987
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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