VPAP Adapt SV, VPAP Tx, S9 VPAP Tx
K-Number: K161487 · 2016-09-09
ApplicantResmed, Ltd.
Decision Date2016-09-09
Product CodeMNS
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
VPAP Adapt SV, VPAP Tx, S9 VPAP Tx is a medical device manufactured by Resmed, Ltd.. It received FDA 510(k) clearance on 2016-09-09 under approval number K161487. The device is classified under product code MNS. It was reviewed by the AN advisory panel. Product code MNS falls under the category of Neurology, which encompasses devices for neurological diagnosis and monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VPAP Adapt SV, VPAP Tx, S9 VPAP Tx?
VPAP Adapt SV, VPAP Tx, S9 VPAP Tx 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 K161487.
When was VPAP Adapt SV, VPAP Tx, S9 VPAP Tx approved by the FDA?
VPAP Adapt SV, VPAP Tx, S9 VPAP Tx received FDA 510(k) clearance on 2016-09-09, under approval number K161487.
What company makes VPAP Adapt SV, VPAP Tx, S9 VPAP Tx?
VPAP Adapt SV, VPAP Tx, S9 VPAP Tx is manufactured by Resmed, Ltd..
What is the FDA product code for VPAP Adapt SV, VPAP Tx, S9 VPAP Tx?
The FDA product code for VPAP Adapt SV, VPAP Tx, S9 VPAP Tx is MNS. This falls under the Neurology category.
Other Devices by Resmed, Ltd.
Related Devices (Code: MNS)
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.