The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Gf-ue160-al5 Ultrasound Endoscope.
| Device ID | K051541 |
| 510k Number | K051541 |
| Device Name: | GF-UE160-AL5 ULTRASOUND ENDOSCOPE |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Neil E Devine INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-06-10 |
| Decision Date | 2005-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170360428 | K051541 | 000 |
| 04953170062865 | K051541 | 000 |
| 04953170062971 | K051541 | 000 |
| 04953170203107 | K051541 | 000 |
| 04953170310546 | K051541 | 000 |
| 04953170355349 | K051541 | 000 |
| 04953170355974 | K051541 | 000 |
| 04953170356148 | K051541 | 000 |
| 04953170356261 | K051541 | 000 |
| 14953170058780 | K051541 | 000 |