The following data is part of a premarket notification filed by The Olympus Optical Co. with the FDA for Evis Exera Colonovideoscope Cf-q160 Al/i And Pcf-160 Al/i.
| Device ID | K001241 |
| 510k Number | K001241 |
| Device Name: | EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville, NY 11747 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville, NY 11747 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-18 |
| Decision Date | 2000-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170339691 | K001241 | 000 |
| 04953170339684 | K001241 | 000 |
| 04953170307638 | K001241 | 000 |
| 04953170307621 | K001241 | 000 |
| 04953170229473 | K001241 | 000 |
| 04953170229466 | K001241 | 000 |
| 04953170202537 | K001241 | 000 |
| 04953170202476 | K001241 | 000 |
| 04953170067495 | K001241 | 000 |