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FDA 510(k)

Visby Medical Sexual Health Test

K-Number: K220407 · 2023-03-07

ApplicantVisby Medical
Decision Date2023-03-07
Product CodeQEP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Visby Medical Sexual Health Test is a medical device manufactured by Visby Medical. It received FDA 510(k) clearance on 2023-03-07 under approval number K220407. The device is classified under product code QEP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Visby Medical Sexual Health Test?

Visby Medical Sexual Health Test is a medical device that received FDA 510(k) clearance on 2023-03-07. It is manufactured by Visby Medical. The 510(k) number is K220407.

When was Visby Medical Sexual Health Test approved by the FDA?

Visby Medical Sexual Health Test received FDA 510(k) clearance on 2023-03-07, under approval number K220407.

What company makes Visby Medical Sexual Health Test?

Visby Medical Sexual Health Test is manufactured by Visby Medical.

What is the FDA product code for Visby Medical Sexual Health Test?

The FDA product code for Visby Medical Sexual Health Test is QEP.

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Other Devices by Visby Medical

K200748Visby Medical Sexual Health

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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