Enlight 2100

Ventilatory Electrical Impedance Tomograph

Timpel S.A.

The following data is part of a premarket notification filed by Timpel S.a. with the FDA for Enlight 2100.

Pre-market Notification Details

Device IDK211135
510k NumberK211135
Device Name:Enlight 2100
ClassificationVentilatory Electrical Impedance Tomograph
Applicant Timpel S.A. R. Simao Alvares, 356 Cj. 41/42 - Pinheiros Sao Paulo,  BR 05417-020
ContactRafael Holzhacker
CorrespondentPaul Dryden
ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg,  FL  33704
Product CodeQEB  
CFR Regulation Number868.1505 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-16
Decision Date2022-01-06

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