S10 Kirra

Ventilator, Non-continuous (respirator)

ResMed Pty Ltd

The following data is part of a premarket notification filed by Resmed Pty Ltd with the FDA for S10 Kirra.

Pre-market Notification Details

Device IDK203126
510k NumberK203126
Device Name:S10 Kirra
ClassificationVentilator, Non-continuous (respirator)
Applicant ResMed Pty Ltd 1 Elizabeth Macarthur Drive Bella Vista,  AU 2053
ContactPeter Jennings
CorrespondentSheila Bruschi
ResMed Corp 9001 Spectrum Center Boulevard San Diego,  CA  92123
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-19
Decision Date2020-12-18

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