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 |