Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES

K-Number: K081468 · 2008-08-25

ApplicantSunrise Medical
Decision Date2008-08-25
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 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 2008-08-25 under 510(k) number K081468. 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 PORTABLE OXYGEN CONCENTRATOR, 306 SERIES?

DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES is a medical device that received FDA 510(k) clearance on 2008-08-25. The listed applicant is Sunrise Medical. The 510(k) number is K081468.

When did DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES receive FDA 510(k) clearance?

DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES received FDA 510(k) clearance on 2008-08-25, under 510(k) number K081468.

Who is the listed applicant for DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 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 PORTABLE OXYGEN CONCENTRATOR, 306 SERIES?

The FDA product code for DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES is CAW.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SYSTEMK071397DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIESK071689DEVILBISS INTELLIPAP MODEL DV 5 SERIES

View all 14 devices →

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.

↑