The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Rhino-laryngo Videoscope Olympus Enf-vh, Rhino-laryngo Videoscope Olympus Enf-v3.
| Device ID | K221638 |
| 510k Number | K221638 |
| Device Name: | Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Contact | Shinichiro Kawachi |
| Correspondent | Brenda M Geary Olympus Corporation Of The Americas 800 West Park Drive Westborough, MA 01581 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-06 |
| Decision Date | 2022-09-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170411403 | K221638 | 000 |
| 04953170411366 | K221638 | 000 |
| 04953170310447 | K221638 | 000 |
| 04953170310416 | K221638 | 000 |
| 04953170434693 | K221638 | 000 |