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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07898966433573 | K211135 | 000 |
| 07898966433337 | K211135 | 000 |
| 07898966433320 | K211135 | 000 |
| 07898966433016 | K211135 | 000 |
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| 07898959841989 | K211135 | 000 |
| 07898959841972 | K211135 | 000 |
| 07898959841965 | K211135 | 000 |
| 07898959841958 | K211135 | 000 |
| 07898959841941 | K211135 | 000 |
| 07898959841934 | K211135 | 000 |
| 07898959841927 | K211135 | 000 |
| 07898959841910 | K211135 | 000 |
| 07898959841903 | K211135 | 000 |
| 07898959841897 | K211135 | 000 |
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| 07898959841873 | K211135 | 000 |
| 07898966433368 | K211135 | 000 |
| 07898966433375 | K211135 | 000 |
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| 07898966433580 | K211135 | 000 |
| 07898966433610 | K211135 | 000 |
| 07898966433627 | K211135 | 000 |
| 07898966433634 | K211135 | 000 |
| 07898966433450 | K211135 | 000 |
| 07898966433443 | K211135 | 000 |
| 07898966433436 | K211135 | 000 |
| 07898966433429 | K211135 | 000 |
| 07898966433412 | K211135 | 000 |
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| 07898966433351 | K211135 | 000 |
| 07898966433344 | K211135 | 000 |
| 07898966433399 | K211135 | 000 |
| 07898966433382 | K211135 | 000 |
| 07898959841002 | K211135 | 000 |