510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190536Substantially Equivalent

Mediracer NCS

Mediracer Ltd., Oulu, FI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190536 is the FDA 510(k) clearance record for Mediracer NCS, a class II device, cleared for Mediracer OY on under FDA product code JXE (Device, Nerve Conduction Velocity Measurement). FDA records list one 510(k) clearance for Mediracer OY. As of , FDA records show no recalls naming K190536.

Clearance record

Decision date
Received
(205 days to decision)
Product code
JXE Device, Nerve Conduction Velocity Measurement
Regulation
21 CFR 882.1550
Device class
Class II
Review panel
Neurology
Applicant
Mediracer OY Rantakatu 4, Oulu, FI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JXE

Trailing 12 months

FDA records hold no clearances under product code JXE in the trailing twelve months.

FDA records show no clearances under product code JXE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JXE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260