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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Prolira B.V.. It received FDA 510(k) clearance on 2023-02-02 under 510(k) 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. The listed applicant is Prolira B.V.. The 510(k) number is K222671.

When did DeltaScan Patch receive FDA 510(k) clearance?

DeltaScan Patch received FDA 510(k) clearance on 2023-02-02, under 510(k) number K222671.

Who is the listed applicant for DeltaScan Patch?

The FDA 510(k) record lists Prolira B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DeltaScan Patch?

The FDA product code for DeltaScan Patch is GXY.

Other records listing Prolira B.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222680DeltaScan Monitor

Related Devices (Code: GXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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