FDA 510(k)

VPAP Adapt SV, VPAP Tx, S9 VPAP Tx

K-Number: K161487 · 2016-09-09

Decision Date2016-09-09

Product CodeMNS

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

VPAP Adapt SV, VPAP Tx, S9 VPAP Tx is the device name listed in this FDA 510(k) record. The listed applicant is Resmed, Ltd.. It received FDA 510(k) clearance on 2016-09-09 under 510(k) 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. The listed applicant is Resmed, Ltd.. The 510(k) number is K161487.

When did VPAP Adapt SV, VPAP Tx, S9 VPAP Tx receive FDA 510(k) clearance?

VPAP Adapt SV, VPAP Tx, S9 VPAP Tx received FDA 510(k) clearance on 2016-09-09, under 510(k) number K161487.

Who is the listed applicant for VPAP Adapt SV, VPAP Tx, S9 VPAP Tx?

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 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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT02811588HomeVent ( Connect) Registry: EU COPD Home NIV RegistryCOMPLETED NCT07011966ASV Therapy for InsomniaRECRUITING NCT07336654Circadian Rhythm Monitoring StudyNOT_YET_RECRUITING NCT07485582Exploration of Current and New Technologies for Accuracy of Diagnosing OSANOT_YET_RECRUITING NCT07785310PAP-NAP Device Clinical StudyNOT_YET_RECRUITING

Other records listing Resmed, Ltd. as applicant

K253553Orion K254104ResScan Essentials K251889myAir K251657Personalized Therapy Comfort Settings (PTCS)K250624myAir K241939EasyCare Tx 2

View all 22 devices →

Related Devices (Code: MNS)

K251889myAirResmed Corp K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.K251661Mariana Minerva; Mariana NimbusResmed Pty , Ltd.K240778Vivo 1, Vivo 2Breas Medical AB K231064ReddyPort ElbowSmd Manufacturing, LLC K213169BPAP SystemBMC Medical Co., Ltd.

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.