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FDA 510(k)

DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST

K-Number: K091919 · 2009-09-28

ApplicantSunrise Medical
Decision Date2009-09-28
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST is the device name listed in this FDA 510(k) record. The listed applicant is Sunrise Medical. It received FDA 510(k) clearance on 2009-09-28 under 510(k) number K091919. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST?

DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST is a medical device that received FDA 510(k) clearance on 2009-09-28. The listed applicant is Sunrise Medical. The 510(k) number is K091919.

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

DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST received FDA 510(k) clearance on 2009-09-28, under 510(k) number K091919.

Who is the listed applicant for DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST?

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 S/ST?

The FDA product code for DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST is BZD.

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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 SERIESK093070DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIESK082209DEVILBISS 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: BZD)

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.

K261262Altis Full Face MaskRespironics, Inc.K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC 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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