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FDA 510(k) Application Details - K022249
Device Classification Name
Standard Polysomnograph With Electroencephalograph
More FDA Info for this Device
510(K) Number
K022249
Device Name
Standard Polysomnograph With Electroencephalograph
Applicant
TELEDIAGNOSTIC SYSTEMS, INC.
1757 EAST BAYSHORE RD., #24
REDWOOD CITY, CA 94063-4151 US
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Contact
LARRY WOODARD
Other 510(k) Applications for this Contact
Regulation Number
882.1400
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Classification Product Code
OLV
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More FDA Info for this Product Code
Date Received
07/12/2002
Decision Date
12/31/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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