The following data is part of a premarket notification filed by Olympus Optical Co., Ltd. with the FDA for Olympus Eu-c60 Eus Exera Compact Endoscopic Ultrasound Center.
| Device ID | K010591 |
| 510k Number | K010591 |
| Device Name: | OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER |
| Classification | Endoscopic Ultrasound System, Gastroenterology-urology |
| Applicant | OLYMPUS OPTICAL CO., LTD. 2951 ISHIKAWA-CHO HACHIOJI-SHI Tokyo, JP 192-8507 |
| Contact | Tsuyoshi Yanai |
| Correspondent | Mark Job TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | ODG |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-02-28 |
| Decision Date | 2001-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170360442 | K010591 | 000 |
| 04953170061929 | K010591 | 000 |
| 04953170062124 | K010591 | 000 |
| 04953170137181 | K010591 | 000 |
| 04953170137518 | K010591 | 000 |
| 04953170355868 | K010591 | 000 |
| 04953170355875 | K010591 | 000 |
| 04953170355882 | K010591 | 000 |
| 04953170356018 | K010591 | 000 |
| 04953170356162 | K010591 | 000 |
| 04953170356216 | K010591 | 000 |
| 14953170058889 | K010591 | 000 |