Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K172079 |
Device Name |
Avail |
Applicant |
Omron Healthcare, Inc. |
1925 West Field Court |
lake forest,
IL
60045
|
|
Applicant Contact |
renee thornborough |
Correspondent |
Experien Group |
224 Airport Parkway, Suite 250 |
san jose,
CA
95110
|
|
Correspondent Contact |
ronald s. warren |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/10/2017 |
Decision Date | 10/19/2017 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|