FDA 510(k)

StrokeViewer Perfusion

K-Number: K231570 · 2023-12-14

Decision Date2023-12-14

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

StrokeViewer Perfusion is the device name listed in this FDA 510(k) record. The listed applicant is Nico-Lab B.V.. It received FDA 510(k) clearance on 2023-12-14 under 510(k) number K231570. 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 StrokeViewer Perfusion?

StrokeViewer Perfusion is a medical device that received FDA 510(k) clearance on 2023-12-14. The listed applicant is Nico-Lab B.V.. The 510(k) number is K231570.

When did StrokeViewer Perfusion receive FDA 510(k) clearance?

StrokeViewer Perfusion received FDA 510(k) clearance on 2023-12-14, under 510(k) number K231570.

Who is the listed applicant for StrokeViewer Perfusion?

The FDA 510(k) record lists Nico-Lab B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for StrokeViewer Perfusion?

The FDA product code for StrokeViewer Perfusion is LLZ.

Other records listing Nico-Lab B.V. 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

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