The following data is part of a premarket notification filed by Computer Motion, Inc. with the FDA for Hermes Operating Room Control Center With The Wom 20l Insufflator.
| Device ID | K980787 |
| 510k Number | K980787 |
| Device Name: | HERMES OPERATING ROOM CONTROL CENTER WITH THE WOM 20L INSUFFLATOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | COMPUTER MOTION, INC. 130 CREMONA DR., SUITE B Goleta, CA 93117 |
| Contact | Douglas P Bueschel |
| Correspondent | Douglas P Bueschel COMPUTER MOTION, INC. 130 CREMONA DR., SUITE B Goleta, CA 93117 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-02 |
| Decision Date | 1998-07-13 |
| Summary: | summary |