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FDA 510(k)

OXYCON-ALPHA

K-Number: K942230 · 1995-03-20

ApplicantMijnhardt B.V.
Decision Date1995-03-20
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYCON-ALPHA is the device name listed in this FDA 510(k) record. The listed applicant is Mijnhardt B.V.. It received FDA 510(k) clearance on 1995-03-20 under 510(k) number K942230. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXYCON-ALPHA?

OXYCON-ALPHA is a medical device that received FDA 510(k) clearance on 1995-03-20. The listed applicant is Mijnhardt B.V.. The 510(k) number is K942230.

When did OXYCON-ALPHA receive FDA 510(k) clearance?

OXYCON-ALPHA received FDA 510(k) clearance on 1995-03-20, under 510(k) number K942230.

Who is the listed applicant for OXYCON-ALPHA?

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

What is the FDA product code for OXYCON-ALPHA?

The FDA product code for OXYCON-ALPHA is BTY.

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Related Devices (Code: BTY)

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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