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 |