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FDA 510(k)

CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615

K-Number: K982243 · 1998-11-19

ApplicantCanogen International , Ltd.
Decision Date1998-11-19
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615 is the device name listed in this FDA 510(k) record. The listed applicant is Canogen International , Ltd.. It received FDA 510(k) clearance on 1998-11-19 under 510(k) number K982243. 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 CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615?

CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615 is a medical device that received FDA 510(k) clearance on 1998-11-19. The listed applicant is Canogen International , Ltd.. The 510(k) number is K982243.

When did CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615 receive FDA 510(k) clearance?

CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615 received FDA 510(k) clearance on 1998-11-19, under 510(k) number K982243.

Who is the listed applicant for CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615?

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

What is the FDA product code for CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615?

The FDA product code for CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615 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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