Mediracer NCS— 510(k) K190536

Substantially Equivalent

Mediracer OY

FDA 510(k) clearance K190536 for Mediracer NCS, Substantially Equivalent on 2019-09-25. Applicant: Mediracer OY. Device class: 2.

Clearance details

Applicant: Mediracer OY
Product code: Code JXE
Device class: Class 2
Regulation: 21 CFR 882.1550
Advisory panel: Neurology
Date received: 2019-03-04
Decision date: 2019-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oulu, FI

Download summary PDF View on FDA.gov ↗

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