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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K092970
Device Name GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H
Applicant
General Meditech, Inc.
Suite 5d, # 19, Ln. 999
Zhongshan # 2 Rd.(S)
Shanghai,  CN 200030
Applicant Contact LEE FU
Correspondent
General Meditech, Inc.
Suite 5d, # 19, Ln. 999
Zhongshan # 2 Rd.(S)
Shanghai,  CN 200030
Correspondent Contact LEE FU
Regulation Number870.1025
Classification Product Code
MHX  
Date Received09/25/2009
Decision Date 02/02/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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