510(k) K250464
- Device
- Enlight 2100 (TPL-E2103-0)
- Applicant
- Timpel S.A.
- 510(k) number
- K250464
- Product code
- QEB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-09-10
- Date received
- 2025-02-18
- Regulation
- 868.1505
- Classification name
- Ventilatory Electrical Impedance Tomograph
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Rafael Holzhacker
- Address
- Rua Simão Álvares, 356 Cj 41/42 São Paulo BR 05.417-020 05.417-020
FDA Registration Numbers#
- 3029845
- 3016509761
- 3004149774
- 3013853674