The following data is part of a premarket notification filed by Computer Motion, Inc. with the FDA for Modification To Hermes Operating Room Control Center.
Device ID | K003222 |
510k Number | K003222 |
Device Name: | MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER |
Classification | Laryngoscope, Endoscope |
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 | GCI |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-10-16 |
Decision Date | 2000-11-03 |