Enlight 1810

Ventilatory Electrical Impedance Tomograph

Timpel Inc.

The following data is part of a De Novo classification by Timpel Inc. with the FDA for Enlight 1810.

Pre-market Notification Details

DeNovo IDDEN170072
Device Name:Enlight 1810
ClassificationVentilatory Electrical Impedance Tomograph
Applicant Timpel Inc. r. Simao Alvares 356 Cj.41-pinheiros Sao Paulo-sp,  BR 05417-020
ContactRafael Holzhacker
Product CodeQEB  
CFR Regulation Number868.1505 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardAnesthesiology
Classification AdvisoryAnesthesiology
TypeDirect
Date Received2017-09-29
Decision Date2018-12-20
Reclassification Order:Reclassification Order

NIH GUDID Devices

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