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FDA 510(k)

S10 Kirra

K-Number: K203126 · 2020-12-18

ApplicantResmed Pty , Ltd.
Decision Date2020-12-18
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

S10 Kirra is a medical device manufactured by Resmed Pty , Ltd.. It received FDA 510(k) clearance on 2020-12-18 under approval number K203126. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S10 Kirra?

S10 Kirra is a medical device that received FDA 510(k) clearance on 2020-12-18. It is manufactured by Resmed Pty , Ltd.. The 510(k) number is K203126.

When was S10 Kirra approved by the FDA?

S10 Kirra received FDA 510(k) clearance on 2020-12-18, under approval number K203126.

What company makes S10 Kirra?

S10 Kirra is manufactured by Resmed Pty , Ltd..

What is the FDA product code for S10 Kirra?

The FDA product code for S10 Kirra is BZD.

Other Devices by Resmed Pty , Ltd.

K242547AirFit F20 Mask System; AirFit F20 NM Mask System K251661Mariana Minerva; Mariana Nimbus

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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