The following data is part of a premarket notification filed by El..en. Electroic Engineering Spa with the FDA for Deka Tiac 1.
| Device ID | K183371 |
| 510k Number | K183371 |
| Device Name: | Deka Tiac 1 |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | El..En. Electroic Engineering SpA via Baldanzese 17 Calenzano, IT 50041 |
| Contact | Paolo Peruzzi |
| Correspondent | Paolo Peruzzi El..En. Electroic Engineering SpA via Baldanzese 17 Calenzano, IT 50041 |
| Product Code | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-06 |
| Decision Date | 2019-12-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08057017760511 | K183371 | 000 |
| 08057017760405 | K183371 | 000 |