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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 K010732
Device Name VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM)
Applicant
Telemedic Systems, Inc.
P.O.Box 3515
Redmond,  WA  98073
Applicant Contact STENEN CHERNOFF
Correspondent
Telemedic Systems, Inc.
P.O.Box 3515
Redmond,  WA  98073
Correspondent Contact STENEN CHERNOFF
Regulation Number870.2300
Classification Product Code
MWI  
Date Received03/12/2001
Decision Date 09/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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