510(k) K222897
- Device
- Enlight 2100
- Applicant
- Timpel S.A.
- 510(k) number
- K222897
- Product code
- QEB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-03-07
- Date received
- 2022-09-23
- 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
- No
Applicant Contact#
- Contact
- Rafael Holtzhacker
- Address
- R. Simao Alvares, 356 Cj. 41/42 - Pinheiros Sao Paulo BR 05417-020 05417-020
FDA Registration Numbers#
- 3029845
- 3016509761
- 3004149774
- 3013853674