Device Classification Name |
neurological stereotaxic instrument
|
510(k) Number |
K142024 |
FOIA Releasable 510(k) |
K142024
|
Device Name |
BRIGHTMATTER NAVIGATION SYSTEM |
Applicant |
SYNAPTIVE MEDICAL INC. |
MARS CENTER, SOUTH TOWER, 101 COLLEGE STREET, SUITE 200 |
TORONTO,
CA
M5G1L7
|
|
Applicant Contact |
CAMERON PIRON |
Correspondent |
SYNAPTIVE MEDICAL INC. |
MARS CENTER, SOUTH TOWER, 101 COLLEGE STREET, SUITE 200 |
TORONTO,
CA
M5G1L7
|
|
Correspondent Contact |
CAMERON PIRON |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 07/25/2014 |
Decision Date | 04/02/2015 |
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
|
|
|