Device Classification Name |
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
|
510(k) Number |
K894097 |
Device Name |
NTI-1000 |
Applicant |
NEUROTEK, INC. |
601 N. MURLEN, SUITE 16 |
OLATHE,
KS
66062
|
|
Applicant Contact |
RAY B SMITH |
Correspondent |
NEUROTEK, INC. |
601 N. MURLEN, SUITE 16 |
OLATHE,
KS
66062
|
|
Correspondent Contact |
RAY B SMITH |
Regulation Number | 882.5800
|
Classification Product Code |
|
Date Received | 06/09/1989 |
Decision Date | 09/25/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|