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)

MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR

K-Number: K050430 · 2005-08-04

ApplicantMerits Health Products Co., Ltd.
Decision Date2005-08-04
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Merits Health Products Co., Ltd.. It received FDA 510(k) clearance on 2005-08-04 under 510(k) number K050430. 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 MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR?

MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR is a medical device that received FDA 510(k) clearance on 2005-08-04. The listed applicant is Merits Health Products Co., Ltd.. The 510(k) number is K050430.

When did MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR receive FDA 510(k) clearance?

MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR received FDA 510(k) clearance on 2005-08-04, under 510(k) number K050430.

Who is the listed applicant for MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR?

The FDA 510(k) record lists Merits Health Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR?

The FDA product code for MERITS HEALTH PRODUCTS 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 Merits Health Products Co., Ltd. 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.

K220529Merits P335 Powered WheelchairK122357MERITS MODEL P322FWD POWERED WHEELCHAIRK113577MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIRK092859MERITS MODEL N SERIES NEBULIZER COMPRESSORSK091716MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORYK073110MERITS E600 SERIES STAIR LIFT

View all 17 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.

↑