Device Classification Name |
Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
|
510(k) Number |
K111073 |
Device Name |
SURGIVISION INC. CLEARPOINT SYSTEM |
Applicant |
SURGI-VISION, INC. |
5 MUSICK |
IRVINE,
CA
92618
|
|
Applicant Contact |
EDWARD WADDELL |
Correspondent |
SURGI-VISION, INC. |
5 MUSICK |
IRVINE,
CA
92618
|
|
Correspondent Contact |
EDWARD WADDELL |
Regulation Number | 882.4560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/18/2011 |
Decision Date | 06/22/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|