The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Tracheal Intubation Fiberscope Olympus Lf-p, Visera Tracheal Intubation Videoscope Olympus Lf Type V.
| Device ID | K221631 |
| 510k Number | K221631 |
| Device Name: | Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hichioji-shi Tokyo, JP 192-8507 |
| Contact | Shinichiro Kawachi |
| Correspondent | Brenda Geary Olympus Corporation Of The Americas 800 West Park Drive Westborough, MA 01581 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-06 |
| Decision Date | 2022-09-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170340246 | K221631 | 000 |
| 04953170156250 | K221631 | 000 |
| 04953170051098 | K221631 | 000 |
| 04953170452932 | K221631 | 000 |