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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electromyograph, Diagnostic
510(k) Number K922488
Device Name PHASIS ELECTROMYOGRAPH
Applicant
Biosound, Inc.
6110 Bollinger Rd.
San Jose,  CA  95129
Applicant Contact WILLIAM E MCKAY
Correspondent
Biosound, Inc.
6110 Bollinger Rd.
San Jose,  CA  95129
Correspondent Contact WILLIAM E MCKAY
Regulation Number890.1375
Classification Product Code
IKN  
Date Received05/27/1992
Decision Date 03/02/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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