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FDA 510(k)

DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES

K-Number: K093070 · 2010-01-26

ApplicantSunrise Medical
Decision Date2010-01-26
Product CodeMNS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Sunrise Medical. It received FDA 510(k) clearance on 2010-01-26 under 510(k) number K093070. 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 DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES?

DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES is a medical device that received FDA 510(k) clearance on 2010-01-26. The listed applicant is Sunrise Medical. The 510(k) number is K093070.

When did DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES receive FDA 510(k) clearance?

DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES received FDA 510(k) clearance on 2010-01-26, under 510(k) number K093070.

Who is the listed applicant for DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES?

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

What is the FDA product code for DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES?

The FDA product code for DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES is MNS. This falls under the Neurology category.

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Other records listing Sunrise Medical 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.

K123975QUICKIE & ZIPPIE SERIESK091919DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/STK082209DEVILBISS DV5M SMARTLINK SYSTEMK081468DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIESK071397DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIESK071689DEVILBISS INTELLIPAP MODEL DV 5 SERIES

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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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