The following data is part of a De Novo classification by Timpel Inc. with the FDA for Enlight 1810.
| DeNovo ID | DEN170072 |
| Device Name: | Enlight 1810 |
| Classification | Ventilatory Electrical Impedance Tomograph |
| Applicant | Timpel Inc. r. Simao Alvares 356 Cj.41-pinheiros Sao Paulo-sp, BR 05417-020 |
| Contact | Rafael Holzhacker |
| Product Code | QEB |
| CFR Regulation Number | 868.1505 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Anesthesiology |
| Classification Advisory | Anesthesiology |
| Type | Direct |
| Date Received | 2017-09-29 |
| Decision Date | 2018-12-20 |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07898959841729 | DEN170072 | 000 |
| 07898966433290 | DEN170072 | 000 |
| 07898959841767 | DEN170072 | 000 |
| 07898959841750 | DEN170072 | 000 |
| 07898959841743 | DEN170072 | 000 |
| 07898959841736 | DEN170072 | 000 |
| 07898966433245 | DEN170072 | 000 |
| 07898966433238 | DEN170072 | 000 |
| 07898966433221 | DEN170072 | 000 |
| 07898966433207 | DEN170072 | 000 |
| 07898966433191 | DEN170072 | 000 |
| 07898966433184 | DEN170072 | 000 |
| 07898966433177 | DEN170072 | 000 |
| 07898966433160 | DEN170072 | 000 |
| 07898966433306 | DEN170072 | 000 |
| 07898959841170 | DEN170072 | 000 |
| 07898959841187 | DEN170072 | 000 |
| 07898959841712 | DEN170072 | 000 |
| 07898959841705 | DEN170072 | 000 |
| 07898959841699 | DEN170072 | 000 |
| 07898959841682 | DEN170072 | 000 |
| 07898959841675 | DEN170072 | 000 |
| 07898959841668 | DEN170072 | 000 |
| 07898959841651 | DEN170072 | 000 |
| 07898959841644 | DEN170072 | 000 |
| 07898959841415 | DEN170072 | 000 |
| 07898959841279 | DEN170072 | 000 |
| 07898959841262 | DEN170072 | 000 |
| 07898959841200 | DEN170072 | 000 |
| 07898959841194 | DEN170072 | 000 |
| 07898966433146 | DEN170072 | 000 |