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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 a medical device manufactured by Resmed, Ltd.. It received FDA 510(k) clearance on 2018-06-15 under approval 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. It is manufactured by Resmed, Ltd.. The 510(k) number is K180497.

When was Scone Mask approved by the FDA?

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

What company makes Scone Mask?

Scone Mask is manufactured by Resmed, Ltd..

What is the FDA product code for Scone Mask?

The FDA product code for Scone Mask is BZD.

Other Devices by Resmed, Ltd.

K160836Menai System K161978AirFit N20 K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV K161487VPAP Adapt SV, VPAP Tx, S9 VPAP Tx K152068Astral 100/150 K153563AirFit F20

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Related Devices (Code: BZD)

K160836Menai SystemResmed, Ltd. K161978AirFit N20Resmed, Ltd. K160127iCodeConnect3B Medical, Inc. K153505F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd. K153387Luna CPAP and Auto CPAP System3B Medical, 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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