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)

5 LPM OXYGEN CONCENTRATOR

K-Number: K953815 · 1995-11-09

ApplicantDevilbiss Health Care, Inc.
Decision Date1995-11-09
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

5 LPM OXYGEN CONCENTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Devilbiss Health Care, Inc.. It received FDA 510(k) clearance on 1995-11-09 under 510(k) number K953815. 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 5 LPM OXYGEN CONCENTRATOR?

5 LPM OXYGEN CONCENTRATOR is a medical device that received FDA 510(k) clearance on 1995-11-09. The listed applicant is Devilbiss Health Care, Inc.. The 510(k) number is K953815.

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

5 LPM OXYGEN CONCENTRATOR received FDA 510(k) clearance on 1995-11-09, under 510(k) number K953815.

Who is the listed applicant for 5 LPM OXYGEN CONCENTRATOR?

The FDA 510(k) record lists Devilbiss Health Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 5 LPM OXYGEN CONCENTRATOR?

The FDA product code for 5 LPM OXYGEN CONCENTRATOR 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 Devilbiss Health Care, 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.

K963349DEVILBISS 8650DK970289COMPRESSOR/NEBULIZER #3650K961126PULSE DOSE SERIESK950849MODEL #7354K952491MODEL 7355K952249JET NEBULIZER

View all 29 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.

↑