The following data is part of a premarket notification filed by Verathon Medical (canada) Ulc with the FDA for Glidescope Bflex 2.8 Single-use Bronchoscope.
| Device ID | K211947 |
| 510k Number | K211947 |
| Device Name: | GlideScope BFlex 2.8 Single-Use Bronchoscope |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Verathon Medical (Canada) ULC 2227 Douglas Road Burnaby, CA V5c 5a9 |
| Contact | Teresa Davidson |
| Correspondent | Teresa Davidson Verathon Medical (Canada) ULC 2227 Douglas Road Burnaby, CA V5c 5a9 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-23 |
| Decision Date | 2021-11-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10879123007534 | K211947 | 000 |
| 10879123008548 | K211947 | 000 |