Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K200511 |
Device Name |
ROSA ONE Brain application |
Applicant |
Medtech S.A. |
ZAC Eureka - 900 Rue du Mas de Verchant |
Montpellier,
FR
34000
|
|
Applicant Contact |
Serge Tabet |
Correspondent |
Medtech S.A. |
ZAC Eureka - 900 Rue du Mas de Verchant |
Montpellier,
FR
34000
|
|
Correspondent Contact |
Serge Tabet |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 03/02/2020 |
Decision Date | 05/29/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|