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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 K896886
Device Name ARTEC RESPOND PULMONARY RESUSCITATOR
Applicant
ARTEC ENVIRONMENTAL MONITORING DIVISION
8804 BASH ST.
SUITE A, P.O. BOX 50627
INDIANAPOLIS,  IN  46256
Applicant Contact E NOTARIANNI
Correspondent
ARTEC ENVIRONMENTAL MONITORING DIVISION
8804 BASH ST.
SUITE A, P.O. BOX 50627
INDIANAPOLIS,  IN  46256
Correspondent Contact E NOTARIANNI
Regulation Number868.5915
Classification Product Code
BTM  
Date Received12/08/1989
Decision Date 02/06/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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