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FDA 510(k)

Scone Mask

K-Number: K180497 · 2018-06-15

ApplicantResmed, Ltd.
Decision Date2018-06-15
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Scone Mask is the device name listed in this FDA 510(k) record. The listed applicant is Resmed, Ltd.. It received FDA 510(k) clearance on 2018-06-15 under 510(k) number K180497. 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 Scone Mask?

Scone Mask is a medical device that received FDA 510(k) clearance on 2018-06-15. The listed applicant is Resmed, Ltd.. The 510(k) number is K180497.

When did Scone Mask receive FDA 510(k) clearance?

Scone Mask received FDA 510(k) clearance on 2018-06-15, under 510(k) number K180497.

Who is the listed applicant for Scone Mask?

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

What is the FDA product code for Scone Mask?

The FDA product code for Scone Mask is BZD.

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Other records listing Resmed, 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.

K253553OrionK254104ResScan EssentialsK251889myAirK251657Personalized Therapy Comfort Settings (PTCS)K250624myAirK241939EasyCare Tx 2

View all 22 devices →

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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