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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K983919
Device Name EMS MOUTH TO MASK RESUSCITATORS
Applicant
Engineered Medical Systems
8529 Zionsville Rd.
P.O. Box 681514
Indianapolis,  IN  46268
Applicant Contact JEFF QUINN
Correspondent
Engineered Medical Systems
8529 Zionsville Rd.
P.O. Box 681514
Indianapolis,  IN  46268
Correspondent Contact JEFF QUINN
Regulation Number868.5870
Classification Product Code
CBP  
Date Received11/04/1998
Decision Date 04/07/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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