The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Airway Mobilescope.
| Device ID | K201300 |
| 510k Number | K201300 |
| Device Name: | Airway Mobilescope |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Sheri L. Musgnung Olympus Corporation Of The America 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034 -0610 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-15 |
| Decision Date | 2021-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170318320 | K201300 | 000 |
| 04953170144011 | K201300 | 000 |
| 04953170054372 | K201300 | 000 |
| 04953170407260 | K201300 | 000 |
| 04953170407208 | K201300 | 000 |
| 04953170407147 | K201300 | 000 |
| 04953170071386 | K201300 | 000 |
| 04953170437953 | K201300 | 000 |