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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, airway pressure (includes gauge and/or alarm)
510(k) Number K110119
Device Name PRESSURE MANOMETER
Applicant
NEOFORCE GROUP INC
35 COMMERCE DRIVE
IVYLAND,  PA  18974
Applicant Contact MONICA FERRANTE
Correspondent
NEOFORCE GROUP INC
35 COMMERCE DRIVE
IVYLAND,  PA  18974
Correspondent Contact MONICA FERRANTE
Regulation Number868.2600
Classification Product Code
CAP  
Date Received01/18/2011
Decision Date 06/10/2011
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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