510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003661Substantially Equivalent

Socrates Robotic Telemonitoring System

Computer Motion, Inc., Goleta CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003661 is the FDA 510(k) clearance record for SOCRATES ROBOTIC TELEMONITORING SYSTEM, a class II device, cleared for Computer Motion, Inc. on under FDA product code NEQ (Device, Telemedicine, Robotic). FDA records list 26 510(k) clearances for Computer Motion, Inc., from to . As of , FDA records show no recalls naming K003661.

Clearance record

Decision date
Received
(311 days to decision)
Product code
NEQ Device, Telemedicine, Robotic
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Computer Motion, Inc. 130 Cremona Dr., Suite B, Goleta CA
510(k) summary
Summary
Third party review
No

Clearances, product code NEQ

Trailing 12 months

FDA records hold no clearances under product code NEQ in the trailing twelve months.

FDA records show no clearances under product code NEQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NEQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260