S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV
K-Number: K160822 · 2016-09-09
ApplicantResmed, Ltd.
Decision Date2016-09-09
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV is a medical device manufactured by Resmed, Ltd.. It received FDA 510(k) clearance on 2016-09-09 under approval number K160822. 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 S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV?
S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV is a medical device that received FDA 510(k) clearance on 2016-09-09. It is manufactured by Resmed, Ltd.. The 510(k) number is K160822.
When was S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV approved by the FDA?
S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV received FDA 510(k) clearance on 2016-09-09, under approval number K160822.
What company makes S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV?
S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV is manufactured by Resmed, Ltd..
What is the FDA product code for S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV?
The FDA product code for S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV is BZD.
Other Devices by Resmed, Ltd.
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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.