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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#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QEB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243765LuMon(TM) SystemSentec AG2025-08-07
K222466AirTomBilab2023-06-30
K222897Enlight 2100Timpel S.A.2023-03-07
K211135Enlight 2100Timpel S.A.2022-01-06
DEN170072Enlight 1810Timpel, Inc.2018-12-20