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)

EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR

K-Number: K043520 · 2005-10-21

ApplicantEmg Technology Co., Ltd.
Decision Date2005-10-21
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Emg Technology Co., Ltd.. It received FDA 510(k) clearance on 2005-10-21 under 510(k) number K043520. 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 EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR?

EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR is a medical device that received FDA 510(k) clearance on 2005-10-21. The listed applicant is Emg Technology Co., Ltd.. The 510(k) number is K043520.

When did EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR receive FDA 510(k) clearance?

EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR received FDA 510(k) clearance on 2005-10-21, under 510(k) number K043520.

Who is the listed applicant for EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR?

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

What is the FDA product code for EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR?

The FDA product code for EMG CTA01-XXX SERIES PURO 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 Emg Technology 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.

K112421EMG SUCTION UNITK072634EMG TRITON -COMP,MODEL NCA01-XXX SERIESK063448EMG AC/DC SUCTION UNITK062888MIDDLE WHEEL DRIVE POWER CHAIR, CWD01K052438EMG HANDLE NEBULIZER NB02 SERIESK043238COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES

View all 11 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.

↑