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FDA 510(k) Application Details - K110119
Device Classification Name
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
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510(K) Number
K110119
Device Name
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Applicant
NEOFORCE GROUP INC
35 COMMERCE DRIVE
IVYLAND, PA 18974 US
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Contact
MONICA FERRANTE
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Regulation Number
868.2600
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Classification Product Code
CAP
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More FDA Info for this Product Code
Date Received
01/18/2011
Decision Date
06/10/2011
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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