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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 K924610
Device Name BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT
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 Number868.5915
Classification Product Code
BTM  
Date Received09/11/1992
Decision Date 04/06/1993
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
Recalls CDRH Recalls
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