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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 a medical device manufactured by Resmed, Ltd.. It received FDA 510(k) clearance on 2018-04-26 under approval 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. It is manufactured by Resmed, Ltd.. The 510(k) number is K172875.

When was Astral 100/150 approved by the FDA?

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

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.

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: CBK)

K153046HAMILTON-MR1Hamilton Medical AG K152068Astral 100/150Resmed, Ltd. K143035Flight 60 VentilatorFlight Medical Innovations , Ltd. K151252Puritan Bennett 840 Series Ventilator SystemCovidien LP K162738Puritan Bennett 980 Ventilator SystemCovidien K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies

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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