The following data is part of a premarket notification filed by Computer Motion, Inc. with the FDA for Aesop (automated Endoscopic System For Optimal Pos.
Device ID | K931783 |
510k Number | K931783 |
Device Name: | AESOP (AUTOMATED ENDOSCOPIC SYSTEM FOR OPTIMAL POS |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | COMPUTER MOTION, INC. 700 THIRTEENTH ST. N.W. SUITE 1200 Washington, DC 20005 |
Contact | Thomas Scarlett |
Correspondent | Thomas Scarlett COMPUTER MOTION, INC. 700 THIRTEENTH ST. N.W. SUITE 1200 Washington, DC 20005 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-09 |
Decision Date | 1993-11-22 |