DeltaScan Patch
K-Number: K222671 · 2023-02-02
ApplicantProlira B.V.
Decision Date2023-02-02
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
DeltaScan Patch is a medical device manufactured by Prolira B.V.. It received FDA 510(k) clearance on 2023-02-02 under approval number K222671. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DeltaScan Patch?
DeltaScan Patch is a medical device that received FDA 510(k) clearance on 2023-02-02. It is manufactured by Prolira B.V.. The 510(k) number is K222671.
When was DeltaScan Patch approved by the FDA?
DeltaScan Patch received FDA 510(k) clearance on 2023-02-02, under approval number K222671.
What company makes DeltaScan Patch?
DeltaScan Patch is manufactured by Prolira B.V..
What is the FDA product code for DeltaScan Patch?
The FDA product code for DeltaScan Patch is GXY.
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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.