The following data is part of a premarket notification filed by Computer Motion, Inc. with the FDA for Socrates Robotic Telemonitoring System.
Device ID | K013804 |
510k Number | K013804 |
Device Name: | SOCRATES ROBOTIC TELEMONITORING SYSTEM |
Classification | Device, Telemedicine, Robotic |
Applicant | COMPUTER MOTION, INC. 130 CREMONA DR., SUITE B Goleta, CA 93117 |
Contact | David U Thomas |
Correspondent | David U Thomas COMPUTER MOTION, INC. 130 CREMONA DR., SUITE B Goleta, CA 93117 |
Product Code | NEQ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-11-15 |
Decision Date | 2001-12-10 |
Summary: | summary |