The following data is part of a premarket notification filed by El.en Electronic Engineering Spa with the FDA for Deka Smartperio.
| Device ID | K213658 |
| 510k Number | K213658 |
| Device Name: | DEKA SMARTPERIO |
| Classification | Laser, Dental, Soft Tissue |
| Applicant | El.En Electronic Engineering Spa Via Baldanzese 17 Calenzano, FL 50041 |
| Contact | Paolo Peruzzi |
| Correspondent | Paolo Peruzzi El.En Electronic Engineering Spa Via Baldanzese 17 Calenzano, FL 50041 |
| Product Code | NVK |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-19 |
| Decision Date | 2022-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08057017760528 | K213658 | 000 |