Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Mediracer NCS

K-Number: K190536 · 2019-09-25

ApplicantMediracer OY
Decision Date2019-09-25
Product CodeJXE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Mediracer NCS is the device name listed in this FDA 510(k) record. The listed applicant is Mediracer OY. It received FDA 510(k) clearance on 2019-09-25 under 510(k) number K190536. The device is classified under product code JXE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mediracer NCS?

Mediracer NCS is a medical device that received FDA 510(k) clearance on 2019-09-25. The listed applicant is Mediracer OY. The 510(k) number is K190536.

When did Mediracer NCS receive FDA 510(k) clearance?

Mediracer NCS received FDA 510(k) clearance on 2019-09-25, under 510(k) number K190536.

Who is the listed applicant for Mediracer NCS?

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

What is the FDA product code for Mediracer NCS?

The FDA product code for Mediracer NCS is JXE.

Related Devices (Code: JXE)

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.

K240189NM-01/CPT neurometer (NM-01/CPT)Mde Orvosbiológiai Kutató, Fejleszto,

Official Source

View on FDA Database →

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

↑