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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 the device name listed in this FDA 510(k) record. The listed applicant is Visby Medical. It received FDA 510(k) clearance on 2021-08-26 under 510(k) 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. The listed applicant is Visby Medical. The 510(k) number is K200748.

When did Visby Medical Sexual Health receive FDA 510(k) clearance?

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

Who is the listed applicant for Visby Medical Sexual Health?

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

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

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

Other records listing Visby Medical as applicant

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.

K253971Visby Medical Flu and COVID-19 TestK251501Visby Medical Men's Sexual Health TestK242526Visby Medical Respiratory Health TestK220407Visby Medical Sexual Health Test

Related Devices (Code: QEP)

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.

K260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systemsRoche Molecular Systems, Inc.K253759cobas liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.K253756cobas liat CT/NG nucleic acid testRoche Molecular Systems, Inc.K251501Visby Medical Men's Sexual Health TestVisby Medical, Inc.K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton,K240217cobas® liat CT/NG nucleic acid testRoche Molecular Systems, Inc.

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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