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FDA 510(k)

DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES

K-Number: K053240 · 2006-02-03

ApplicantSunrise Medical
Decision Date2006-02-03
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 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 2006-02-03 under 510(k) number K053240. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES?

DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES is a medical device that received FDA 510(k) clearance on 2006-02-03. The listed applicant is Sunrise Medical. The 510(k) number is K053240.

When did DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES receive FDA 510(k) clearance?

DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES received FDA 510(k) clearance on 2006-02-03, under 510(k) number K053240.

Who is the listed applicant for DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 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 OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES?

The FDA product code for DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES is CAW.

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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/STK082209DEVILBISS DV5M SMARTLINK SYSTEMK081468DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIESK071397DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES

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Related Devices (Code: CAW)

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.

K254289Portable Oxygen Concentrator (OX-1A-E, OX-1B)Oxytek Medical Technology Co., Ltd.K260171Portable Oxygen Concentrator (PO1 5B, PO1 6B)BMC Medical Co., Ltd.K252399Portable Oxygen ConcentratorHonsun (Nantong) Co., Ltd.K252965Oxygen Concentrator (OX-5A, OX-5C)Oxytek Medical Technology Co., Ltd.K252407OxyGo Portable Oxygen Concentrator (1400-7000)Mv Life, LLCK253549DeVilbiss 5 Liter Oxygen Concentrator (555)Devilbiss Healthcare, LLC

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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