510(k) DEN170072
DEN170072 is an FDA 510(k) premarket notification submitted by Timpel, Inc. for the device "Enlight 1810". The FDA issued a decision of De Novo Granted on December 20, 2018. The device falls under product code QEB (Ventilatory Electrical Impedance Tomograph), a Class II device regulated under 21 CFR 868.1505. Timpel, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 20, 2018
- Date Received
- September 29, 2017
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilatory Electrical Impedance Tomograph
- Device Class
- Class II
- Regulation Number
- 868.1505
- Review Panel
- AN
- Submission Type
A ventilatory electrical impedance tomograph is a prescription non-invasive, non-radiological ventilatory device that provides an assessment of local impedance variation within a cross-section of a patients thorax.