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FDA 510(k)

S9 VPAP TX

K-Number: K123511 · 2013-03-21

ApplicantResmed, Ltd.
Decision Date2013-03-21
Product CodeMNS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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 2013-03-21 under 510(k) number K123511. 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 S9 VPAP TX?

S9 VPAP TX is a medical device that received FDA 510(k) clearance on 2013-03-21. The listed applicant is Resmed, Ltd.. The 510(k) number is K123511.

When did S9 VPAP TX receive FDA 510(k) clearance?

S9 VPAP TX received FDA 510(k) clearance on 2013-03-21, under 510(k) number K123511.

Who is the listed applicant for 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 S9 VPAP TX?

The FDA product code for S9 VPAP TX 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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