The following data is part of a premarket notification filed by Prosurg, Inc with the FDA for Neo-bronchoscope -digital Video Bronchoscopy System(rigid/flexible).
| Device ID | K152466 |
| 510k Number | K152466 |
| Device Name: | Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | PROSURG, INC 2193 Trade Zone Blvd San Jose, CA 95131 |
| Contact | Ashvin Desai |
| Correspondent | Ashvin Desai PROSURG, INC 2193 Trade Zone Blvd San Jose, CA 95131 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-31 |
| Decision Date | 2016-05-19 |
| Summary: | summary |