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FDA 510(k)

AcuityPDR

K-Number: K200726 · 2020-04-13

ApplicantRadmedix, LLC
Decision Date2020-04-13
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AcuityPDR is a medical device manufactured by Radmedix, LLC. It received FDA 510(k) clearance on 2020-04-13 under approval number K200726. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AcuityPDR?

AcuityPDR is a medical device that received FDA 510(k) clearance on 2020-04-13. It is manufactured by Radmedix, LLC. The 510(k) number is K200726.

When was AcuityPDR approved by the FDA?

AcuityPDR received FDA 510(k) clearance on 2020-04-13, under approval number K200726.

What company makes AcuityPDR?

AcuityPDR is manufactured by Radmedix, LLC.

What is the FDA product code for AcuityPDR?

The FDA product code for AcuityPDR is IZL.

Other Devices by Radmedix, LLC

K201058Accuvue+ 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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