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FDA 510(k)

DEVILBISS 5 LITER OXYGEN CONCENTRATOR

K-Number: K991722 · 1999-11-03

ApplicantSunrise Medical Hhg, Inc.
Decision Date1999-11-03
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DEVILBISS 5 LITER OXYGEN CONCENTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Sunrise Medical Hhg, Inc.. It received FDA 510(k) clearance on 1999-11-03 under 510(k) number K991722. 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 5 LITER OXYGEN CONCENTRATOR?

DEVILBISS 5 LITER OXYGEN CONCENTRATOR is a medical device that received FDA 510(k) clearance on 1999-11-03. The listed applicant is Sunrise Medical Hhg, Inc.. The 510(k) number is K991722.

When did DEVILBISS 5 LITER OXYGEN CONCENTRATOR receive FDA 510(k) clearance?

DEVILBISS 5 LITER OXYGEN CONCENTRATOR received FDA 510(k) clearance on 1999-11-03, under 510(k) number K991722.

Who is the listed applicant for DEVILBISS 5 LITER OXYGEN CONCENTRATOR?

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

What is the FDA product code for DEVILBISS 5 LITER OXYGEN CONCENTRATOR?

The FDA product code for DEVILBISS 5 LITER OXYGEN CONCENTRATOR is CAW.

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Other records listing Sunrise Medical Hhg, Inc. 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.

K083249QUICKIE RHYTHMK012437DEVILBISS SLEEP RECORDER MODEL # RM60K020329DEVILBISS PD1000K020900DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEMK011229DEVILBISS 9000 SERIES CPAP, MODEL 9001K003626DEVILBISS HUMIDIFIER

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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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