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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
Predetermined Change
Control Plan Authorized		 No
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