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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 K993194
Device Name RUSCH MANUAL RESUSCITATOR BAG
Applicant
RUSCH, INC.
2450 MEADOWBROOK PKWY.
DULUTH,  GA  30096
Applicant Contact RONALD YOUNG
Correspondent
RUSCH, INC.
2450 MEADOWBROOK PKWY.
DULUTH,  GA  30096
Correspondent Contact RONALD YOUNG
Regulation Number868.5915
Classification Product Code
BTM  
Date Received09/23/1999
Decision Date 03/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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