510(k) K013804

Device
SOCRATES ROBOTIC TELEMONITORING SYSTEM
Applicant
COMPUTER MOTION, INC.
510(k) number
K013804
Product code
NEQ  
Decision
Substantially Equivalent (SESE)
Decision date
2001-12-10
Date received
2001-11-15
Regulation
876.1500
Classification name
Device, Telemedicine, Robotic
Medical specialty
Gastroenterology/Urology
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DAVID U THOMAS
Address
130 Cremona Dr., Suite B Goleta CA US 93117 93117

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NEQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K003661SOCRATES ROBOTIC TELEMONITORING SYSTEMComputer Motion, Inc.2001-10-05

Legacy Summary#

summary

FDA Review#

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