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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 E. Bayshore Rd., #24
Redwood City,  CA  94063 -4151
Applicant Contact LARRY WOODARD
Correspondent
Telediagnostic Systems, Inc.
1757 E. 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
Predetermined Change
Control Plan Authorized		 No
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