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FDA 510(k)

PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400

K-Number: K073242 · 2008-01-03

ApplicantDelphi Medical Systems
Decision Date2008-01-03
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400 is the device name listed in this FDA 510(k) record. The listed applicant is Delphi Medical Systems. It received FDA 510(k) clearance on 2008-01-03 under 510(k) number K073242. 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 PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400?

PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400 is a medical device that received FDA 510(k) clearance on 2008-01-03. The listed applicant is Delphi Medical Systems. The 510(k) number is K073242.

When did PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400 receive FDA 510(k) clearance?

PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400 received FDA 510(k) clearance on 2008-01-03, under 510(k) number K073242.

Who is the listed applicant for PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400?

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

What is the FDA product code for PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400?

The FDA product code for PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400 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 Delphi Medical Systems 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.

K093332DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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