The following data is part of a premarket notification filed by Sanovas, Inc. with the FDA for Pulmovia Working Channel.
| Device ID | K150280 |
| 510k Number | K150280 |
| Device Name: | PulmoVia Working Channel |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | SANOVAS, INC. 2597 Kerner Blvd San Rafael, CA 94901 |
| Contact | Roy Morgan |
| Correspondent | Cynthia Nolte ICON Plc 62 Forest Street Suite 300 Marlborough, MA 01752 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-05 |
| Decision Date | 2015-06-11 |
| Summary: | summary |