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)

HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009

K-Number: K012037 · 2002-01-17

ApplicantAirsep Corp.
Decision Date2002-01-17
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009 is the device name listed in this FDA 510(k) record. The listed applicant is Airsep Corp.. It received FDA 510(k) clearance on 2002-01-17 under 510(k) number K012037. 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 HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009?

HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009 is a medical device that received FDA 510(k) clearance on 2002-01-17. The listed applicant is Airsep Corp.. The 510(k) number is K012037.

When did HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009 receive FDA 510(k) clearance?

HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009 received FDA 510(k) clearance on 2002-01-17, under 510(k) number K012037.

Who is the listed applicant for HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009?

The FDA 510(k) record lists Airsep Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009?

The FDA product code for HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009 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 Airsep Corp. 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.

K101154CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-LK080348OXISCAN II DATA MANAGEMENT SYSTEMK020324LIFESTYLE OXYGEN CONCENTRATORK000963DA VINCHI EEG AND EMG/EP SYSTEMSK001579IMPULSE SELECTK001467DA VINCHI EMG/EP ISA1004EP

View all 18 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.

↑