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FDA 510(k)

VPAP ST-A

K-Number: K113288 · 2012-03-29

ApplicantResmed, Ltd.
Decision Date2012-03-29
Product CodeMNS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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 2012-03-29 under 510(k) number K113288. 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 ST-A?

VPAP ST-A is a medical device that received FDA 510(k) clearance on 2012-03-29. The listed applicant is Resmed, Ltd.. The 510(k) number is K113288.

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

VPAP ST-A received FDA 510(k) clearance on 2012-03-29, under 510(k) number K113288.

Who is the listed applicant for 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 VPAP ST-A?

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

Other records listing Resmed, Ltd. as applicant

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.

K183512Moore Park MaskK180497Scone MaskK172875Astral 100/150K170924AirFit F20K171212AirFit N20K161492Juno VPAP ST-A

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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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