VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER

Amplifier, Physiological Signal

TELEDIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Telediagnostic Systems, Inc. with the FDA for Vista Graph Polysomnography Amplifier.

Pre-market Notification Details

Device IDK904222
510k NumberK904222
Device Name:VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER
ClassificationAmplifier, Physiological Signal
Applicant TELEDIAGNOSTIC SYSTEMS, INC. 2053 SUTTER ST. San Francisco,  CA  94115
ContactLarry Woodard
CorrespondentLarry Woodard
TELEDIAGNOSTIC SYSTEMS, INC. 2053 SUTTER ST. San Francisco,  CA  94115
Product CodeGWL  
CFR Regulation Number882.1835 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-09-13
Decision Date1991-01-18

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