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FDA 510(k)

OXYGEN CONCENTRATOR RESPIRATORY SUPPOR

K-Number: K831819 · 1983-11-22

ApplicantEagle Medical Equipment Co.
Decision Date1983-11-22
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYGEN CONCENTRATOR RESPIRATORY SUPPOR is the device name listed in this FDA 510(k) record. The listed applicant is Eagle Medical Equipment Co.. It received FDA 510(k) clearance on 1983-11-22 under 510(k) number K831819. 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 OXYGEN CONCENTRATOR RESPIRATORY SUPPOR?

OXYGEN CONCENTRATOR RESPIRATORY SUPPOR is a medical device that received FDA 510(k) clearance on 1983-11-22. The listed applicant is Eagle Medical Equipment Co.. The 510(k) number is K831819.

When did OXYGEN CONCENTRATOR RESPIRATORY SUPPOR receive FDA 510(k) clearance?

OXYGEN CONCENTRATOR RESPIRATORY SUPPOR received FDA 510(k) clearance on 1983-11-22, under 510(k) number K831819.

Who is the listed applicant for OXYGEN CONCENTRATOR RESPIRATORY SUPPOR?

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

What is the FDA product code for OXYGEN CONCENTRATOR RESPIRATORY SUPPOR?

The FDA product code for OXYGEN CONCENTRATOR RESPIRATORY SUPPOR 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 Eagle Medical Equipment Co. 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.

K062724ACCUPULSE PULSE OXIMETERK955129OXYPULSE EOC I, EOC II & EOC R

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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