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FDA 510(k)

Hydrozid Precise

K-Number: K221897 · 2023-05-30

ApplicantBibawo Medical A/S
Decision Date2023-05-30
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Hydrozid Precise is a medical device manufactured by Bibawo Medical A/S. It received FDA 510(k) clearance on 2023-05-30 under approval number K221897. 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 Precise?

Hydrozid Precise is a medical device that received FDA 510(k) clearance on 2023-05-30. It is manufactured by Bibawo Medical A/S. The 510(k) number is K221897.

When was Hydrozid Precise approved by the FDA?

Hydrozid Precise received FDA 510(k) clearance on 2023-05-30, under approval number K221897.

What company makes Hydrozid Precise?

Hydrozid Precise is manufactured by Bibawo Medical A/S.

What is the FDA product code for Hydrozid Precise?

The FDA product code for Hydrozid Precise is GEH.

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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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