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510(k) K211135

Device
Enlight 2100
Applicant
Timpel S.A.
510(k) number
K211135
Product code
QEB  
Decision
Substantially Equivalent (SESE)
Decision date
2022-01-06
Date received
2021-04-16
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 Holzhacker
Address
R. Simao Alvares, 356 Cj. 41/42 - Pinheiros Sao Paulo BR 05417-020 05417-020

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
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
DEN170072Enlight 1810Timpel, Inc.2018-12-20

Legacy Summary#

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FDA Review#

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