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)
501(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

Device IdentifiersubmissionNumberSupplement
07898959841729 DEN170072 000
07898959841187 DEN170072 000
07898959841194 DEN170072 000
07898959841200 DEN170072 000
07898959841262 DEN170072 000
07898959841279 DEN170072 000
07898959841415 DEN170072 000
07898959841644 DEN170072 000
07898959841651 DEN170072 000
07898959841668 DEN170072 000
07898959841675 DEN170072 000
07898959841682 DEN170072 000
07898959841699 DEN170072 000
07898959841705 DEN170072 000
07898959841712 DEN170072 000
07898959841170 DEN170072 000

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