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FDA 510(k)

OXYGEN RICH AIR SUPPLY UNIT-MODEL 390

K-Number: K781074 · 1978-08-31

ApplicantXorbox
Decision Date1978-08-31
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYGEN RICH AIR SUPPLY UNIT-MODEL 390 is the device name listed in this FDA 510(k) record. The listed applicant is Xorbox. It received FDA 510(k) clearance on 1978-08-31 under 510(k) number K781074. 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 RICH AIR SUPPLY UNIT-MODEL 390?

OXYGEN RICH AIR SUPPLY UNIT-MODEL 390 is a medical device that received FDA 510(k) clearance on 1978-08-31. The listed applicant is Xorbox. The 510(k) number is K781074.

When did OXYGEN RICH AIR SUPPLY UNIT-MODEL 390 receive FDA 510(k) clearance?

OXYGEN RICH AIR SUPPLY UNIT-MODEL 390 received FDA 510(k) clearance on 1978-08-31, under 510(k) number K781074.

Who is the listed applicant for OXYGEN RICH AIR SUPPLY UNIT-MODEL 390?

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

What is the FDA product code for OXYGEN RICH AIR SUPPLY UNIT-MODEL 390?

The FDA product code for OXYGEN RICH AIR SUPPLY UNIT-MODEL 390 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.

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Other records listing Xorbox 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.

K760704OXYGEN-RICH

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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