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FDA 510(k)

Accuvue+

K-Number: K201058 · 2020-05-06

ApplicantRadmedix, LLC
Decision Date2020-05-06
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Accuvue+ is the device name listed in this FDA 510(k) record. The listed applicant is Radmedix, LLC. It received FDA 510(k) clearance on 2020-05-06 under 510(k) number K201058. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Accuvue+?

Accuvue+ is a medical device that received FDA 510(k) clearance on 2020-05-06. The listed applicant is Radmedix, LLC. The 510(k) number is K201058.

When did Accuvue+ receive FDA 510(k) clearance?

Accuvue+ received FDA 510(k) clearance on 2020-05-06, under 510(k) number K201058.

Who is the listed applicant for Accuvue+?

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

What is the FDA product code for Accuvue+?

The FDA product code for Accuvue+ is MQB.

Other records listing Radmedix, LLC 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.

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Related Devices (Code: MQB)

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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