Device Classification Name |
Transducer, Tremor
|
510(k) Number |
K221772 |
Device Name |
NeuroRPM |
Applicant |
New Touch Digital Inc. |
3124 Dumbarton Street NW |
Washington,
DC
20007
|
|
Applicant Contact |
Chan Lee |
Correspondent |
New Touch Digital Inc. |
3124 Dumbarton Street NW |
Washington,
DC
20007
|
|
Correspondent Contact |
Chan Lee |
Regulation Number | 882.1950
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/21/2022 |
Decision Date | 03/17/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|