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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 K991953
Device Name MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION
Applicant
ENGINEERED MEDICAL SYSTEMS
2055 EXECUTIVE DR.
INDIANAPOLIS,  IN  46241
Applicant Contact BONNIE HOLLY
Correspondent
ENGINEERED MEDICAL SYSTEMS
2055 EXECUTIVE DR.
INDIANAPOLIS,  IN  46241
Correspondent Contact BONNIE HOLLY
Regulation Number868.5915
Classification Product Code
BTM  
Date Received06/01/1999
Decision Date 07/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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