The following data is part of a premarket notification filed by Timpel S.a. with the FDA for Enlight 2100.
| Device ID | K211135 |
| 510k Number | K211135 |
| Device Name: | Enlight 2100 |
| Classification | Ventilatory Electrical Impedance Tomograph |
| Applicant | Timpel S.A. R. Simao Alvares, 356 Cj. 41/42 - Pinheiros Sao Paulo, BR 05417-020 |
| Contact | Rafael Holzhacker |
| Correspondent | Paul Dryden ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg, FL 33704 |
| Product Code | QEB |
| CFR Regulation Number | 868.1505 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-16 |
| Decision Date | 2022-01-06 |