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FDA 510(k)

VISIA NEURO

K-Number: K113701 · 2012-02-16

ApplicantMeVis Medical Solutions AG
Decision Date2012-02-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VISIA NEURO is the device name listed in this FDA 510(k) record. The listed applicant is MeVis Medical Solutions AG. It received FDA 510(k) clearance on 2012-02-16 under 510(k) number K113701. 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 VISIA NEURO?

VISIA NEURO is a medical device that received FDA 510(k) clearance on 2012-02-16. The listed applicant is MeVis Medical Solutions AG. The 510(k) number is K113701.

When did VISIA NEURO receive FDA 510(k) clearance?

VISIA NEURO received FDA 510(k) clearance on 2012-02-16, under 510(k) number K113701.

Who is the listed applicant for VISIA NEURO?

The FDA 510(k) record lists MeVis Medical Solutions AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VISIA NEURO?

The FDA product code for VISIA NEURO is LLZ.

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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.

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