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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 a medical device manufactured by Radmedix, LLC. It received FDA 510(k) clearance on 2020-05-06 under approval 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. It is manufactured by Radmedix, LLC. The 510(k) number is K201058.

When was Accuvue+ approved by the FDA?

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

What company makes Accuvue+?

Accuvue+ is manufactured by Radmedix, LLC.

What is the FDA product code for Accuvue+?

The FDA product code for Accuvue+ is MQB.

Other Devices by Radmedix, LLC

K200726AcuityPDR K193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard K210919AcuityDRe K231995AcuityUDR K231709AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4

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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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