FDA.reportPublic FDA data

510(k) DEN170072

Device
Enlight 1810
Applicant
Timpel, Inc.
510(k) number
DEN170072
Product code
QEB
Decision
Unknown (DENG)
Decision date
2018-12-20
Date received
2017-09-29
Regulation
868.1505
Classification name
Ventilatory Electrical Impedance Tomograph
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Direct
Third party reviewed
N

Applicant Contact#

Contact
Rafael Holzhacker
Address
R. Simao Alvares 356 Cj.41-Pinheiros Sao Paulo-Sp BR 05417-020 05417-020

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code QEB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250464Enlight 2100 (TPL-E2103-0)Timpel S.A.2025-09-10
K243765LuMon(TM) SystemSentec AG2025-08-07
K222466AirTomBilab2023-06-30
K222897Enlight 2100Timpel S.A.2023-03-07
K211135Enlight 2100Timpel S.A.2022-01-06