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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K891107
Device Name INDICATENS INDICATOR ELECTRODE MODEL 2
Applicant
Acudata Software
604 Sartori Dr.
Petaluma,  CA  94952
Applicant Contact JOEL ROSSEN
Correspondent
Acudata Software
604 Sartori Dr.
Petaluma,  CA  94952
Correspondent Contact JOEL ROSSEN
Regulation Number882.1320
Classification Product Code
GXY  
Date Received03/02/1989
Decision Date 05/25/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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