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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, galvanic skin response measurement
510(k) Number K992129
Device Name PHAZX VLD-100
Applicant
PHAZX SYSTEMS, INC.
4655 KIRKWOOD COURT
BOULDER,  CO  80301
Applicant Contact LEWIS W WARD
Correspondent
PHAZX SYSTEMS, INC.
4655 KIRKWOOD COURT
BOULDER,  CO  80301
Correspondent Contact LEWIS W WARD
Regulation Number882.1540
Classification Product Code
GZO  
Date Received06/23/1999
Decision Date 09/17/1999
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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