Device Classification Name |
Amplifier, Physiological Signal
|
510(k) Number |
K220631 |
Device Name |
NomadAir PMU810 |
Applicant |
Neurotronics, Inc. |
4500 NW 27th Ave STE C2 |
Gainesville,
FL
32606
|
|
Applicant Contact |
James "Cody" Smith |
Correspondent |
Neurotronics, Inc. |
4500 NW 27th Ave STE C2 |
Gainesville,
FL
32606
|
|
Correspondent Contact |
James "Cody" Smith |
Regulation Number | 882.1835
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/04/2022 |
Decision Date | 07/15/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|