Device Classification Name |
Motor, Drill, Electric
|
510(k) Number |
K193630 |
Device Name |
hekaDrill |
Applicant |
Zethon Ltd |
2 Halton Brook Business Park |
Aylesbury,
GB
hp22 5wf
|
|
Applicant Contact |
Faith Green |
Correspondent |
Zethon Ltd |
2 Halton Brook Business Park |
Aylesbury,
GB
hp22 5wf
|
|
Correspondent Contact |
Faith Green |
Regulation Number | 882.4360
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/26/2019 |
Decision Date | 04/09/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|