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FDA 510(k)

FENZIAN TREATMENT SYSTEM

K-Number: K041575 · 2004-07-16

ApplicantEumedic Limited
Decision Date2004-07-16
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

FENZIAN TREATMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Eumedic Limited. It received FDA 510(k) clearance on 2004-07-16 under 510(k) number K041575. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FENZIAN TREATMENT SYSTEM?

FENZIAN TREATMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2004-07-16. The listed applicant is Eumedic Limited. The 510(k) number is K041575.

When did FENZIAN TREATMENT SYSTEM receive FDA 510(k) clearance?

FENZIAN TREATMENT SYSTEM received FDA 510(k) clearance on 2004-07-16, under 510(k) number K041575.

Who is the listed applicant for FENZIAN TREATMENT SYSTEM?

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

What is the FDA product code for FENZIAN TREATMENT SYSTEM?

The FDA product code for FENZIAN TREATMENT SYSTEM is GZJ.

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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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