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 |