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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Telemedicine, Robotic
510(k) Number K003661
Device Name SOCRATES ROBOTIC TELEMONITORING SYSTEM
Applicant
Computer Motion, Inc.
130 Cremona Dr., Suite B
Goleta,  CA  93117
Applicant Contact DAVID THOMAS
Correspondent
Computer Motion, Inc.
130 Cremona Dr., Suite B
Goleta,  CA  93117
Correspondent Contact DAVID THOMAS
Regulation Number876.1500
Classification Product Code
NEQ  
Date Received11/28/2000
Decision Date 10/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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