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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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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