Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K214058 |
Device Name |
Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer |
Applicant |
ConMed Corporation |
525 French Road |
Utica,
NY
13502
|
|
Applicant Contact |
Kavita Amin |
Correspondent |
ConMed Corporation |
525 French Road |
Utica,
NY
13502
|
|
Correspondent Contact |
Kavita Amin |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 12/27/2021 |
Decision Date | 08/26/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|