Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K183325 |
Device Name |
Modus Nav |
Applicant |
Synaptive Medical Inc. |
555 Richmond Street West, Suite 800 |
Toronto,
CA
M5V 3B1
|
|
Applicant Contact |
Maham Ansari |
Correspondent |
Synaptive Medical Inc. |
555 Richmond Street West, Suite 800 |
Toronto,
CA
M5V 3B1
|
|
Correspondent Contact |
Maham Ansari |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 11/30/2018 |
Decision Date | 07/14/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|