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FDA 510(k)

MODEL 6323 OXYGEN CONCENTRATOR

K-Number: K942082 · 1994-12-08

ApplicantDynotec Corp.
Decision Date1994-12-08
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL 6323 OXYGEN CONCENTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Dynotec Corp.. It received FDA 510(k) clearance on 1994-12-08 under 510(k) number K942082. 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 6323 OXYGEN CONCENTRATOR?

MODEL 6323 OXYGEN CONCENTRATOR is a medical device that received FDA 510(k) clearance on 1994-12-08. The listed applicant is Dynotec Corp.. The 510(k) number is K942082.

When did MODEL 6323 OXYGEN CONCENTRATOR receive FDA 510(k) clearance?

MODEL 6323 OXYGEN CONCENTRATOR received FDA 510(k) clearance on 1994-12-08, under 510(k) number K942082.

Who is the listed applicant for MODEL 6323 OXYGEN CONCENTRATOR?

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

What is the FDA product code for MODEL 6323 OXYGEN CONCENTRATOR?

The FDA product code for MODEL 6323 OXYGEN CONCENTRATOR 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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