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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 the device name listed in this FDA 510(k) record. The listed applicant is Resmed Pty , Ltd.. It received FDA 510(k) clearance on 2020-12-18 under 510(k) 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. The listed applicant is Resmed Pty , Ltd.. The 510(k) number is K203126.

When did S10 Kirra receive FDA 510(k) clearance?

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

Who is the listed applicant for S10 Kirra?

The FDA 510(k) record lists Resmed Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S10 Kirra?

The FDA product code for S10 Kirra is BZD.

Other records listing Resmed Pty , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: BZD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)

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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