Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K202575 |
Device Name |
ClearPoint Array System |
Applicant |
ClearPoint Neuro, Inc. |
5 Musick |
Irvine,
CA
92618
|
|
Applicant Contact |
Pete Piferi |
Correspondent |
Hogan Lovells US LLP |
555 Thirteenth St. NW |
Washington,
DC
20004
|
|
Correspondent Contact |
John Smith |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 09/04/2020 |
Decision Date | 01/22/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|