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FDA 510(k)

MODEL 379 WXYGEN CONCENTRATOR

K-Number: K801523 · 1980-07-14

ApplicantStanley Aviation Corp.
Decision Date1980-07-14
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL 379 WXYGEN CONCENTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Stanley Aviation Corp.. It received FDA 510(k) clearance on 1980-07-14 under 510(k) number K801523. 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 MODEL 379 WXYGEN CONCENTRATOR?

MODEL 379 WXYGEN CONCENTRATOR is a medical device that received FDA 510(k) clearance on 1980-07-14. The listed applicant is Stanley Aviation Corp.. The 510(k) number is K801523.

When did MODEL 379 WXYGEN CONCENTRATOR receive FDA 510(k) clearance?

MODEL 379 WXYGEN CONCENTRATOR received FDA 510(k) clearance on 1980-07-14, under 510(k) number K801523.

Who is the listed applicant for MODEL 379 WXYGEN CONCENTRATOR?

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

What is the FDA product code for MODEL 379 WXYGEN CONCENTRATOR?

The FDA product code for MODEL 379 WXYGEN CONCENTRATOR is CAW.

Related Clinical Trials

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Other records listing Stanley Aviation 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.

K811702MODEL 381 HOME OXYGEN SENTRY

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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