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FDA 510(k)

AcuityDRe

K-Number: K210919 · 2021-04-30

ApplicantRadmedix, LLC
Decision Date2021-04-30
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AcuityDRe is a medical device manufactured by Radmedix, LLC. It received FDA 510(k) clearance on 2021-04-30 under approval number K210919. 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 AcuityDRe?

AcuityDRe is a medical device that received FDA 510(k) clearance on 2021-04-30. It is manufactured by Radmedix, LLC. The 510(k) number is K210919.

When was AcuityDRe approved by the FDA?

AcuityDRe received FDA 510(k) clearance on 2021-04-30, under approval number K210919.

What company makes AcuityDRe?

AcuityDRe is manufactured by Radmedix, LLC.

What is the FDA product code for AcuityDRe?

The FDA product code for AcuityDRe is MQB.

Other Devices by Radmedix, LLC

K201058Accuvue+ K200726AcuityPDR K193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard 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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