The following data is part of a premarket notification filed by The Olympus Optical Co. with the FDA for Evis Exera Gastrointestinal Videoscope Gif-q160z.
| Device ID | K011151 |
| 510k Number | K011151 |
| Device Name: | EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | THE OLYMPUS OPTICAL CO. ENDOSCOPE DIVISION TWO CORPORATE CENTER DRIVE Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler THE OLYMPUS OPTICAL CO. ENDOSCOPE DIVISION TWO CORPORATE CENTER DRIVE Melville, NY 11747 -3157 |
| Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-16 |
| Decision Date | 2001-05-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170339837 | K011151 | 000 |
| 04953170339806 | K011151 | 000 |
| 04953170202308 | K011151 | 000 |
| 04953170156120 | K011151 | 000 |
| 04953170066795 | K011151 | 000 |