NIGHTRON POLYSOMNOGRAPHY SYSTEM


Device Classification Name

standard polysomnograph with electroencephalograph

510(k) Number K022249
Device Name NIGHTRON POLYSOMNOGRAPHY SYSTEM
Original Applicant
TELEDIAGNOSTIC SYSTEMS, INC.
1757 east bayshore rd., #24
redwood city, 
CA 
94063 -4151

Original Contact larry woodard
Regulation Number 882.1400
Classification Product Code
OLV  
Date Received 07/12/2002
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