NIGHTRON POLYSOMNOGRAPHY SYSTEM

Standard Polysomnograph With Electroencephalograph

TELEDIAGNOSTIC SYSTEMS, INC.

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

Pre-market Notification Details

Device IDK022249
510k NumberK022249
Device Name:NIGHTRON POLYSOMNOGRAPHY SYSTEM
ClassificationStandard Polysomnograph With Electroencephalograph
Applicant TELEDIAGNOSTIC SYSTEMS, INC. 1757 EAST BAYSHORE RD., #24 Redwood City,  CA  94063 -4151
ContactLarry Woodard
CorrespondentLarry Woodard
TELEDIAGNOSTIC SYSTEMS, INC. 1757 EAST BAYSHORE RD., #24 Redwood City,  CA  94063 -4151
Product CodeOLV  
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-12
Decision Date2002-12-31

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