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 | K991635 |
| 510k Number | K991635 |
| Device Name: | MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-12 |
| Decision Date | 1999-05-27 |
| Summary: | summary |