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FDA 510(k) Application Details - K991955
Device Classification Name
Ventilator, Emergency, Manual (Resuscitator)
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510(K) Number
K991955
Device Name
Ventilator, Emergency, Manual (Resuscitator)
Applicant
ENGINEERED MEDICAL SYSTEMS
2055 EXECUTIVE DR.
INDIANAPOLIS, IN 46241 US
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Contact
BONNIE HOLLY
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Regulation Number
868.5915
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Classification Product Code
BTM
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Date Received
06/01/1999
Decision Date
07/06/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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