LTV2 Series Ventilators

Ventilator, Continuous, Facility Use

Vyaire Medical Inc

The following data is part of a premarket notification filed by Vyaire Medical Inc with the FDA for Ltv2 Series Ventilators.

Pre-market Notification Details

Device IDK201082
510k NumberK201082
Device Name:LTV2 Series Ventilators
ClassificationVentilator, Continuous, Facility Use
Applicant Vyaire Medical Inc 26125 N. Riverwoods Blvd. Mettawa,  IL  60045
ContactColleen Watson
CorrespondentColleen Watson
Vyaire Medical Inc 26125 N. Riverwoods Blvd. Mettawa,  IL  60045
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-23
Decision Date2021-11-10

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