Device Classification Name |
Bronchoscope (Flexible Or Rigid)
|
510(k) Number |
K183256 |
Device Name |
GlideScope BFlex Single-Use Bronchoscope System |
Applicant |
Verathon Medical (Canada) ULC |
2227 Douglas Road |
Burnaby,
CA
V3W 1P2
|
|
Applicant Contact |
Teresa Davidson |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Mark Job |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 11/21/2018 |
Decision Date | 01/04/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|