FDA 510(k)

nordicMEDiVA

K-Number: K243209 · 2024-10-22

Decision Date2024-10-22

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

nordicMEDiVA is the device name listed in this FDA 510(k) record. The listed applicant is Nordicneurolab AS. It received FDA 510(k) clearance on 2024-10-22 under 510(k) number K243209. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the nordicMEDiVA?

nordicMEDiVA is a medical device that received FDA 510(k) clearance on 2024-10-22. The listed applicant is Nordicneurolab AS. The 510(k) number is K243209.

When did nordicMEDiVA receive FDA 510(k) clearance?

nordicMEDiVA received FDA 510(k) clearance on 2024-10-22, under 510(k) number K243209.

Who is the listed applicant for nordicMEDiVA?

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

What is the FDA product code for nordicMEDiVA?

The FDA product code for nordicMEDiVA is LLZ.

Other records listing Nordicneurolab AS 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.

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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.