The following data is part of a premarket notification filed by Optimize, Inc. with the FDA for Optivu Hdvd System.
| Device ID | K001169 |
| 510k Number | K001169 |
| Device Name: | OPTIVU HDVD SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | OPTIMIZE, INC. 420 BLOSSOM HILL RD. Los Gatos, CA 95032 |
| Contact | Ken Gong |
| Correspondent | Donald James Sheratt INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2000-04-11 |
| Decision Date | 2000-05-16 |