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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cable, Electrode
510(k) Number K935260
Device Name PHYSIOMETRIX CABLE ADAPTER MODIFICATION
Applicant
Physiometrix, Inc.
575 N. Pastoria Ave.
Sunnyvale,  CA  94086
Applicant Contact Claire Andrews
Correspondent
Physiometrix, Inc.
575 N. Pastoria Ave.
Sunnyvale,  CA  94086
Correspondent Contact Claire Andrews
Regulation Number890.1175
Classification Product Code
IKD  
Date Received11/02/1993
Decision Date 12/23/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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