The following data is part of a premarket notification filed by Verathon Medical (canada) Ulc with the FDA for Glidescope Bflex Single-use Bronchoscope System.
| Device ID | K183256 |
| 510k Number | K183256 |
| Device Name: | GlideScope BFlex Single-Use Bronchoscope System |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Verathon Medical (Canada) ULC 2227 Douglas Road Burnaby, CA V3w 1p2 |
| Contact | Teresa Davidson |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-11-21 |
| Decision Date | 2019-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10879123006339 | K183256 | 000 |
| 10879123008562 | K183256 | 000 |