The following data is part of a premarket notification filed by Computer Motion, Inc. with the FDA for Modification To Hermes O.r. Control Center.
Device ID | K031720 |
510k Number | K031720 |
Device Name: | MODIFICATION TO HERMES O.R. CONTROL CENTER |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | COMPUTER MOTION, INC. 130 CREMONA DR., SUITE B Goleta, CA 93117 |
Contact | Keith Lowrey |
Correspondent | Keith Lowrey COMPUTER MOTION, INC. 130 CREMONA DR., SUITE B Goleta, CA 93117 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-06-03 |
Decision Date | 2003-07-11 |
Summary: | summary |