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FDA 510(k)

Juno VPAP ST-A

K-Number: K161492 · 2017-01-19

ApplicantResmed, Ltd.
Decision Date2017-01-19
Product CodeMNS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Juno VPAP ST-A is the device name listed in this FDA 510(k) record. The listed applicant is Resmed, Ltd.. It received FDA 510(k) clearance on 2017-01-19 under 510(k) number K161492. 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 2017-01-19. The listed applicant is Resmed, Ltd.. The 510(k) number is K161492.

When did Juno VPAP ST-A receive FDA 510(k) clearance?

Juno VPAP ST-A received FDA 510(k) clearance on 2017-01-19, under 510(k) number K161492.

Who is the listed applicant for Juno VPAP ST-A?

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 Juno VPAP ST-A?

The FDA product code for Juno VPAP ST-A is MNS. This falls under the Neurology category.

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Other records listing Resmed, Ltd. as applicant

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Related Devices (Code: MNS)

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.

K251889myAirResmed CorpK252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.K251661Mariana Minerva; Mariana NimbusResmed Pty , Ltd.K240778Vivo 1, Vivo 2Breas Medical ABK231064ReddyPort ElbowSmd Manufacturing, LLCK213169BPAP 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.

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