Device Classification Name |
cuff, nerve
|
510(k) Number |
K190246 |
Device Name |
NeuroShield |
Applicant |
Monarch Bioimplants GmbH |
Platz 4 |
Root,
CH
6039
|
|
Applicant Contact |
Rivelino Montenegro |
Correspondent |
Monarch Bioimplants GmbH |
Platz 4 |
Root,
CH
6039
|
|
Correspondent Contact |
Rivelino Montenegro |
Regulation Number | 882.5275
|
Classification Product Code |
|
Date Received | 02/06/2019 |
Decision Date | 05/31/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|