The following data is part of a premarket notification filed by Olympus Optical Co., Ltd. with the FDA for Olympus Xgif-n200h Gastrointestinal Videoscope.
| Device ID | K001766 |
| 510k Number | K001766 |
| Device Name: | OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | OLYMPUS OPTICAL CO., LTD. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-taylor |
| Correspondent | Laura Storms-taylor OLYMPUS OPTICAL CO., LTD. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-12 |
| Decision Date | 2000-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170340376 | K001766 | 000 |
| 04953170286445 | K001766 | 000 |
| 04953170156113 | K001766 | 000 |
| 04953170156106 | K001766 | 000 |
| 04953170154096 | K001766 | 000 |