Ventway Sparrow

Ventilator, Continuous, Facility Use

Inovytech Medical Solutions Ltd.

The following data is part of a premarket notification filed by Inovytech Medical Solutions Ltd. with the FDA for Ventway Sparrow.

Pre-market Notification Details

Device IDK202970
510k NumberK202970
Device Name:Ventway Sparrow
ClassificationVentilator, Continuous, Facility Use
Applicant Inovytech Medical Solutions Ltd. 3 Hanagar Street Hod Hasharon Tel-aviv,  IL 4501306
ContactDana Hofeller
CorrespondentPaul Dryden
c/o ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg,  FL  33704
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-30
Decision Date2021-01-29

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