The following data is part of a premarket notification filed by Computer Motion, Inc. with the FDA for Zeus Microwrist Robotic Surgical System And Accessories.
Device ID | K021152 |
510k Number | K021152 |
Device Name: | ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES |
Classification | System, Surgical, Computer Controlled Instrument |
Applicant | COMPUTER MOTION, INC. 130-B CREMONA DR. Goleta, CA 93117 |
Contact | David Munjal |
Correspondent | David Munjal COMPUTER MOTION, INC. 130-B CREMONA DR. Goleta, CA 93117 |
Product Code | NAY |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-04-10 |
Decision Date | 2002-09-24 |
Summary: | summary |