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FDA 510(k)

Astral 100/150

K-Number: K172875 · 2018-04-26

ApplicantResmed, Ltd.
Decision Date2018-04-26
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Astral 100/150 is the device name listed in this FDA 510(k) record. The listed applicant is Resmed, Ltd.. It received FDA 510(k) clearance on 2018-04-26 under 510(k) number K172875. 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 2018-04-26. The listed applicant is Resmed, Ltd.. The 510(k) number is K172875.

When did Astral 100/150 receive FDA 510(k) clearance?

Astral 100/150 received FDA 510(k) clearance on 2018-04-26, under 510(k) number K172875.

Who is the listed applicant for Astral 100/150?

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 Astral 100/150?

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

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Related Devices (Code: 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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