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FDA 510(k)

HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2

K-Number: K991569 · 1999-08-03

Decision Date1999-08-03
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2 is the device name listed in this FDA 510(k) record. The listed applicant is 02 Marketing Group, Inc.. It received FDA 510(k) clearance on 1999-08-03 under 510(k) number K991569. 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 HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2?

HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2 is a medical device that received FDA 510(k) clearance on 1999-08-03. The listed applicant is 02 Marketing Group, Inc.. The 510(k) number is K991569.

When did HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2 receive FDA 510(k) clearance?

HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2 received FDA 510(k) clearance on 1999-08-03, under 510(k) number K991569.

Who is the listed applicant for HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2?

The FDA 510(k) record lists 02 Marketing Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2?

The FDA product code for HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2 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.

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.

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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