The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Evis Exera Iii Bronchovideoscope Olympus Bf-xp190, Evis Exera Iii Bronchovideoscope Olympus Bf-p190.
| Device ID | K201758 |
| 510k Number | K201758 |
| Device Name: | EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190 |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Anne-marie Keefe Olympus Surigical Technologies Of America 118 Turnpike Road, Suite 120 Southborough, MA 01772 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-29 |
| Decision Date | 2021-01-21 |