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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 K102377
Device Name VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0
Applicant
A Plus Medical
5431 Avenida Encinas
Suite G
Carlsbad,  CA  92008
Applicant Contact THOMAS C LOESCHER
Correspondent
A Plus Medical
5431 Avenida Encinas
Suite G
Carlsbad,  CA  92008
Correspondent Contact THOMAS C LOESCHER
Regulation Number868.2600
Classification Product Code
CAP  
Date Received08/20/2010
Decision Date 11/18/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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