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FDA 510(k)

O2PAK OXYGEN GENERATOR

K-Number: K120566 · 2012-07-24

ApplicantPacific Precision Products
Decision Date2012-07-24
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

O2PAK OXYGEN GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Precision Products. It received FDA 510(k) clearance on 2012-07-24 under 510(k) number K120566. 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 O2PAK OXYGEN GENERATOR?

O2PAK OXYGEN GENERATOR is a medical device that received FDA 510(k) clearance on 2012-07-24. The listed applicant is Pacific Precision Products. The 510(k) number is K120566.

When did O2PAK OXYGEN GENERATOR receive FDA 510(k) clearance?

O2PAK OXYGEN GENERATOR received FDA 510(k) clearance on 2012-07-24, under 510(k) number K120566.

Who is the listed applicant for O2PAK OXYGEN GENERATOR?

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

What is the FDA product code for O2PAK OXYGEN GENERATOR?

The FDA product code for O2PAK OXYGEN GENERATOR is CAW.

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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.

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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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