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FDA 510(k)

SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM

K-Number: K974417 · 1998-06-24

ApplicantResmed Corp
Decision Date1998-06-24
Product CodeMNS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Resmed Corp. It received FDA 510(k) clearance on 1998-06-24 under 510(k) number K974417. 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 SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM?

SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM is a medical device that received FDA 510(k) clearance on 1998-06-24. The listed applicant is Resmed Corp. The 510(k) number is K974417.

When did SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM receive FDA 510(k) clearance?

SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM received FDA 510(k) clearance on 1998-06-24, under 510(k) number K974417.

Who is the listed applicant for SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM?

The FDA 510(k) record lists Resmed Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM?

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

Related Clinical Trials

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Other records listing Resmed Corp 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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