The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Evis Exera Ultrasonic Bronchofibervideoscope, Olympus Model Bf Type Uc160f-ol8.
| Device ID | K060475 |
| 510k Number | K060475 |
| Device Name: | EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8 |
| Classification | Endoscopic Contamination Prevention Sheath |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION TWO CORPORATE CENTER DR. Melville, NY 11747 -9058 |
| Contact | Laura Storms-tyler |
| Correspondent | Neil E Devine INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | ODB |
| Subsequent Product Code | EOQ |
| Subsequent Product Code | ITX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-02-23 |
| Decision Date | 2006-03-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170151767 | K060475 | 000 |