FDA 510(k)

DeltaScan Monitor

K-Number: K222680 · 2023-02-02

Decision Date2023-02-02

Product CodeNCG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

DeltaScan Monitor 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 K222680. The device is classified under product code NCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DeltaScan Monitor?

DeltaScan Monitor 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 K222680.

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

DeltaScan Monitor received FDA 510(k) clearance on 2023-02-02, under 510(k) number K222680.

Who is the listed applicant for DeltaScan Monitor?

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 Monitor?

The FDA product code for DeltaScan Monitor is NCG.

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.

K222671DeltaScan Patch

Related Devices (Code: NCG)

K251936Ceribell Delirium Monitor SystemCeribell, Inc.

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.