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510(k) K991955

MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION by Engineered Medical Systems — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1999
Date Received
June 1, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Manual (Resuscitator)
Device Class
Class II
Regulation Number
868.5915
Review Panel
AN
Submission Type

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