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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Standard Polysomnograph With Electroencephalograph
510(k) Number K022249
Device Name NIGHTRON POLYSOMNOGRAPHY SYSTEM
Applicant
TELEDIAGNOSTIC SYSTEMS, INC.
1757 EAST BAYSHORE RD., #24
REDWOOD CITY,  CA  94063 -4151
Applicant Contact LARRY WOODARD
Correspondent
TELEDIAGNOSTIC SYSTEMS, INC.
1757 EAST BAYSHORE RD., #24
REDWOOD CITY,  CA  94063 -4151
Correspondent Contact LARRY WOODARD
Regulation Number882.1400
Classification Product Code
OLV  
Date Received07/12/2002
Decision Date 12/31/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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