Device Classification Name |
Electrode, Needle
|
510(k) Number |
K190801 |
Device Name |
PressOn Electrode Headset |
Applicant |
Rhythmlink International, LLC |
1140 First Street South |
Columbia,
SC
29209
|
|
Applicant Contact |
Gabriel Orsinger |
Correspondent |
Rhythmlink International, LLC |
1140 First Street South |
Columbia,
SC
29209
|
|
Correspondent Contact |
Gabriel Orsinger |
Regulation Number | 882.1350
|
Classification Product Code |
|
Date Received | 03/29/2019 |
Decision Date | 07/10/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|