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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 (Without Arrhythmia Detection Or Alarms)
510(k) Number K012349
Device Name METAVISION CLINICAL INFORMATION SYSTEM
Applicant
Imdsoft, Ltd.
12300 Twinbrook Pkwy., Suite 625
Rockville,  MD  20852
Applicant Contact T. WHIT ATHEY
Correspondent
Imdsoft, Ltd.
12300 Twinbrook Pkwy., Suite 625
Rockville,  MD  20852
Correspondent Contact T. WHIT ATHEY
Regulation Number870.2300
Classification Product Code
MWI  
Date Received07/24/2001
Decision Date 01/29/2002
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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