Device Classification Name |
neurological stereotaxic instrument
|
510(k) Number |
K200079 |
Device Name |
ClearPoint System and Accessories |
Applicant |
MRI Interventions, Inc |
5 Musick |
Irvine,
CA
92618
|
|
Applicant Contact |
Pete Piferi |
Correspondent |
Hogan Lovells US LLP |
555 Thirteen St. NW |
Washington,
DC
20004
|
|
Correspondent Contact |
John J. Smith |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 01/14/2020 |
Decision Date | 02/13/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|