Device Classification Name |
Ear, Nose, And Throat Stereotaxic Instrument
|
510(k) Number |
K211291 |
Device Name |
Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D |
Applicant |
Fiagon GmbH |
Neuendorfstr. 23b |
Hennigsdorf,
DE
16761
|
|
Applicant Contact |
Dirk Mucha |
Correspondent |
Fiagon GmbH |
Neuendorfstr. 23b |
Hennigsdorf,
DE
16761
|
|
Correspondent Contact |
Dirk Mucha |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 04/28/2021 |
Decision Date | 07/19/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|