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FDA 510(k)

Astral 100/150

K-Number: K152068 · 2016-05-13

ApplicantResmed, Ltd.
Decision Date2016-05-13
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Astral 100/150 is a medical device manufactured by Resmed, Ltd.. It received FDA 510(k) clearance on 2016-05-13 under approval number K152068. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Astral 100/150?

Astral 100/150 is a medical device that received FDA 510(k) clearance on 2016-05-13. It is manufactured by Resmed, Ltd.. The 510(k) number is K152068.

When was Astral 100/150 approved by the FDA?

Astral 100/150 received FDA 510(k) clearance on 2016-05-13, under approval number K152068.

What company makes Astral 100/150?

Astral 100/150 is manufactured by Resmed, Ltd..

What is the FDA product code for Astral 100/150?

The FDA product code for Astral 100/150 is CBK.

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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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