DeltaScan Monitor— 510(k) K222680

Substantially Equivalent

Prolira B.V.

FDA 510(k) clearance K222680 for DeltaScan Monitor, Substantially Equivalent on 2023-02-02. Applicant: Prolira B.V.. Device class: 2.

Clearance details

Applicant: Prolira B.V.
Product code: Code NCG
Device class: Class 2
Regulation: 21 CFR 882.1440
Advisory panel: Neurology
Date received: 2022-09-06
Decision date: 2023-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Utrecht, NL

Download summary PDF View on FDA.gov ↗

Recent devices under product code NCG

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DEN110019 — NEBA SYSTEM2013-07-15

More clearances from Prolira B.V.

K222671 — DeltaScan Patch2023-02-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.