The following data is part of a premarket notification filed by Zethon Ltd with the FDA for Hekadrill.
| Device ID | K193630 |
| 510k Number | K193630 |
| Device Name: | HekaDrill |
| Classification | Motor, Drill, Electric |
| Applicant | Zethon Ltd 2 Halton Brook Business Park Aylesbury, GB Hp22 5wf |
| Contact | Faith Green |
| Correspondent | Faith Green Zethon Ltd 2 Halton Brook Business Park Aylesbury, GB Hp22 5wf |
| Product Code | HBC |
| Subsequent Product Code | ERL |
| Subsequent Product Code | HBB |
| Subsequent Product Code | HBE |
| Subsequent Product Code | HSZ |
| CFR Regulation Number | 882.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-26 |
| Decision Date | 2021-04-09 |