The following data is part of a premarket notification filed by Olympus Corporation with the FDA for Olympus Bf Type Uc160-ol8.
| Device ID | K042140 |
| 510k Number | K042140 |
| Device Name: | OLYMPUS BF TYPE UC160-OL8 |
| Classification | Endoscopic Ultrasound System, Gastroenterology-urology |
| Applicant | OLYMPUS CORPORATION TWO CORPORATE CENTER DRIVE Melville, NY 11747 -3157 |
| Contact | Tina Steffanie-oak |
| Correspondent | Derwyn Reuber INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | ODG |
| Subsequent Product Code | EOQ |
| Subsequent Product Code | FDS |
| Subsequent Product Code | ITX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-08-09 |
| Decision Date | 2004-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170360459 | K042140 | 000 |
| 04953170355981 | K042140 | 000 |
| 04953170175626 | K042140 | 000 |
| 14953170175616 | K042140 | 000 |