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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K972605
Device Name EMS NASAL CPAP MASK
Applicant
Engineered Medical Systems
8529 Zionsville Rd.
P.O. Box 681514
Indianapolis,  IN  46268
Applicant Contact BONNIE HOLLY
Correspondent
Engineered Medical Systems
8529 Zionsville Rd.
P.O. Box 681514
Indianapolis,  IN  46268
Correspondent Contact BONNIE HOLLY
Regulation Number868.5905
Classification Product Code
BZD  
Date Received07/11/1997
Decision Date 01/28/1998
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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