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510(k) K003661

SOCRATES ROBOTIC TELEMONITORING SYSTEM by Computer Motion, Inc. — Product Code NEQ

K003661 is an FDA 510(k) premarket notification submitted by Computer Motion, Inc. for the device "SOCRATES ROBOTIC TELEMONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on October 5, 2001. The device falls under product code NEQ (Device, Telemedicine, Robotic), a Class II device regulated under 21 CFR 876.1500. Computer Motion, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2001
Date Received
November 28, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Telemedicine, Robotic
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Other clearances by Computer Motion, Inc.

  • K031956 — MODIFICATION TO HERMES O.R. CONTROL CENTER (July 17, 2003)
  • K031720 — MODIFICATION TO HERMES O.R. CONTROL CENTER (July 11, 2003)
  • K031382 — MODIFICATION TO HERMES O.R. CONTROL CENTER (June 30, 2003)
  • K030578 — BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM (June 24, 2003)
  • K030718 — SCB COMPUTER MOTION INTERFACE CONTROLLER (June 5, 2003)
  • K030240 — MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER (February 21, 2003)
  • K024294 — MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER (January 8, 2003)
  • K023095 — HERMES OPERATING ROOM CONTROL CENTER (November 15, 2002)
  • K022897 — MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER (October 11, 2002)
  • K021152 — ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES (September 24, 2002)

Other clearances for product code NEQ

  • K013804 — SOCRATES ROBOTIC TELEMONITORING SYSTEM (December 10, 2001)

FDA data resources