Device Classification Name |
media, electroconductive
|
510(k) Number |
K221724 |
Device Name |
Conductive Gel |
Applicant |
Tone-A-Matic International Inc. |
145 Traders East |
Unit 18 |
Mississauga,
CA
L5Z-3L3
|
|
Applicant Contact |
Manuel Chuck |
Correspondent |
Tone-A-Matic International Inc. |
145 Traders East |
Unit 18 |
Mississauga,
CA
L5Z-3L3
|
|
Correspondent Contact |
Manuel Chuck |
Regulation Number | 882.1275
|
Classification Product Code |
|
Date Received | 06/14/2022 |
Decision Date | 09/23/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|