Device Classification Name |
neurological stereotaxic instrument
|
510(k) Number |
K210989 |
Device Name |
Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System |
Applicant |
Brainlab AG |
Olof-Palme-Str. 9 |
Munich,
DE
81829
|
|
Applicant Contact |
Chiara Cunico |
Correspondent |
Brainlab AG |
Olof-Palme-Str. 9 |
Munich,
DE
81829
|
|
Correspondent Contact |
Chiara Cunico |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 04/02/2021 |
Decision Date | 11/12/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|