Device Classification Name |
stimulator, nerve
|
510(k) Number |
K061365 |
Device Name |
CHECKPOINT WITH ACCUSTIM TECHNOLOGY |
Applicant |
NDI MEDICAL, LLC |
ONE CHAGRIN HIGHLANDS |
2000 AUBURN DRIVE, SUITE 320 |
CLEVELAND,
OH
44122
|
|
Applicant Contact |
JULIE GRILL |
Correspondent |
NDI MEDICAL, LLC |
ONE CHAGRIN HIGHLANDS |
2000 AUBURN DRIVE, SUITE 320 |
CLEVELAND,
OH
44122
|
|
Correspondent Contact |
JULIE GRILL |
Regulation Number | 874.1820
|
Classification Product Code |
|
Date Received | 05/16/2006 |
Decision Date | 07/12/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|