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FDA 510(k)

Hydrozid

K-Number: K201740 · 2021-07-07

ApplicantMedilink A/S
Decision Date2021-07-07
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Hydrozid is the device name listed in this FDA 510(k) record. The listed applicant is Medilink A/S. It received FDA 510(k) clearance on 2021-07-07 under 510(k) number K201740. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hydrozid?

Hydrozid is a medical device that received FDA 510(k) clearance on 2021-07-07. The listed applicant is Medilink A/S. The 510(k) number is K201740.

When did Hydrozid receive FDA 510(k) clearance?

Hydrozid received FDA 510(k) clearance on 2021-07-07, under 510(k) number K201740.

Who is the listed applicant for Hydrozid?

The FDA 510(k) record lists Medilink A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hydrozid?

The FDA product code for Hydrozid is GEH.

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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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