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FDA 510(k)

OXYTEC, MODEL 900

K-Number: K043615 · 2005-02-09

ApplicantOxytec Medical Corporation
Decision Date2005-02-09
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYTEC, MODEL 900 is the device name listed in this FDA 510(k) record. The listed applicant is Oxytec Medical Corporation. It received FDA 510(k) clearance on 2005-02-09 under 510(k) number K043615. 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 OXYTEC, MODEL 900?

OXYTEC, MODEL 900 is a medical device that received FDA 510(k) clearance on 2005-02-09. The listed applicant is Oxytec Medical Corporation. The 510(k) number is K043615.

When did OXYTEC, MODEL 900 receive FDA 510(k) clearance?

OXYTEC, MODEL 900 received FDA 510(k) clearance on 2005-02-09, under 510(k) number K043615.

Who is the listed applicant for OXYTEC, MODEL 900?

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

What is the FDA product code for OXYTEC, MODEL 900?

The FDA product code for OXYTEC, MODEL 900 is CAW.

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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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