The following data is part of a premarket notification filed by Otu Medical Inc. with the FDA for Wiscope Digital Bronchoscope System, Wiscope Single-use Digital Flexible Bronchoscope, Wiscope Image System.
| Device ID | K220399 |
| 510k Number | K220399 |
| Device Name: | WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | OTU Medical Inc. 2231 A Fortune Drive San Jose, CA 95131 |
| Contact | Geping Liu |
| Correspondent | Mingzi Hussey Zi-medical 93 Springs Rd Bedford, MA 01730 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-11 |
| Decision Date | 2022-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850023925227 | K220399 | 000 |
| 10850023925210 | K220399 | 000 |
| 10850023925203 | K220399 | 000 |