NightOwl

Ventilatory Effort Recorder

Ectosense Nv

The following data is part of a premarket notification filed by Ectosense Nv with the FDA for Nightowl.

Pre-market Notification Details

Device IDK191031
510k NumberK191031
Device Name:NightOwl
ClassificationVentilatory Effort Recorder
Applicant Ectosense Nv Bosbessenlaan 19A Rotselaar,  BE 3110
ContactBart Van Pee
CorrespondentBart Van Pee
Ectosense Nv Bosbessenlaan 19A Rotselaar,  BE 3110
Product CodeMNR  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyAnesthesiology
510k Review PanelAnesthesiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-18
Decision Date2020-03-06

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