Juno VPAP ST-A
K-Number: K153061 · 2016-04-13
ApplicantResmed, Ltd.
Decision Date2016-04-13
Product CodeMNS
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Juno VPAP ST-A is a medical device manufactured by Resmed, Ltd.. It received FDA 510(k) clearance on 2016-04-13 under approval number K153061. 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 Juno VPAP ST-A?
Juno VPAP ST-A is a medical device that received FDA 510(k) clearance on 2016-04-13. It is manufactured by Resmed, Ltd.. The 510(k) number is K153061.
When was Juno VPAP ST-A approved by the FDA?
Juno VPAP ST-A received FDA 510(k) clearance on 2016-04-13, under approval number K153061.
What company makes Juno VPAP ST-A?
Juno VPAP ST-A is manufactured by Resmed, Ltd..
What is the FDA product code for Juno VPAP ST-A?
The FDA product code for Juno VPAP ST-A 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.