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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier, Physiological Signal
510(k) Number K904222
Device Name VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER
Applicant
TELEDIAGNOSTIC SYSTEMS, INC.
2053 SUTTER ST.
SAN FRANCISCO,  CA  94115
Applicant Contact LARRY WOODARD
Correspondent
TELEDIAGNOSTIC SYSTEMS, INC.
2053 SUTTER ST.
SAN FRANCISCO,  CA  94115
Correspondent Contact LARRY WOODARD
Regulation Number882.1835
Classification Product Code
GWL  
Date Received09/13/1990
Decision Date 01/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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