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FDA 510(k)

Visby Medical Sexual Health

K-Number: K200748 · 2021-08-26

ApplicantVisby Medical
Decision Date2021-08-26
Product CodeQEP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Visby Medical Sexual Health is a medical device manufactured by Visby Medical. It received FDA 510(k) clearance on 2021-08-26 under approval number K200748. 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?

Visby Medical Sexual Health is a medical device that received FDA 510(k) clearance on 2021-08-26. It is manufactured by Visby Medical. The 510(k) number is K200748.

When was Visby Medical Sexual Health approved by the FDA?

Visby Medical Sexual Health received FDA 510(k) clearance on 2021-08-26, under approval number K200748.

What company makes Visby Medical Sexual Health?

Visby Medical Sexual Health is manufactured by Visby Medical.

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

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

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Related PubMed Literature

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Other Devices by Visby Medical

K220407Visby Medical Sexual Health Test

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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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