Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard
K-Number: K193360 · 2020-01-02
ApplicantRadmedix, LLC
Decision Date2020-01-02
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard is a medical device manufactured by Radmedix, LLC. It received FDA 510(k) clearance on 2020-01-02 under approval number K193360. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard?
Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard is a medical device that received FDA 510(k) clearance on 2020-01-02. It is manufactured by Radmedix, LLC. The 510(k) number is K193360.
When was Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard approved by the FDA?
Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard received FDA 510(k) clearance on 2020-01-02, under approval number K193360.
What company makes Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard?
Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard is manufactured by Radmedix, LLC.
What is the FDA product code for Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard?
The FDA product code for Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard is KPR.
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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.