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FDA 510(k)

DEVILBISS DV5M SMARTLINK SYSTEM

K-Number: K082209 · 2008-10-28

ApplicantSunrise Medical
Decision Date2008-10-28
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DEVILBISS DV5M SMARTLINK SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sunrise Medical. It received FDA 510(k) clearance on 2008-10-28 under 510(k) number K082209. 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 DV5M SMARTLINK SYSTEM?

DEVILBISS DV5M SMARTLINK SYSTEM is a medical device that received FDA 510(k) clearance on 2008-10-28. The listed applicant is Sunrise Medical. The 510(k) number is K082209.

When did DEVILBISS DV5M SMARTLINK SYSTEM receive FDA 510(k) clearance?

DEVILBISS DV5M SMARTLINK SYSTEM received FDA 510(k) clearance on 2008-10-28, under 510(k) number K082209.

Who is the listed applicant for DEVILBISS DV5M SMARTLINK SYSTEM?

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 DV5M SMARTLINK SYSTEM?

The FDA product code for DEVILBISS DV5M SMARTLINK SYSTEM 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 SERIESK091919DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/STK081468DEVILBISS 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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