StrokeViewer Perfusion
K-Number: K231570 · 2023-12-14
ApplicantNico-Lab B.V.
Decision Date2023-12-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
StrokeViewer Perfusion is a medical device manufactured by Nico-Lab B.V.. It received FDA 510(k) clearance on 2023-12-14 under approval 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. It is manufactured by Nico-Lab B.V.. The 510(k) number is K231570.
When was StrokeViewer Perfusion approved by the FDA?
StrokeViewer Perfusion received FDA 510(k) clearance on 2023-12-14, under approval number K231570.
What company makes StrokeViewer Perfusion?
StrokeViewer Perfusion is manufactured by Nico-Lab B.V..
What is the FDA product code for StrokeViewer Perfusion?
The FDA product code for StrokeViewer Perfusion is LLZ.
Other Devices by Nico-Lab B.V.
Related Devices (Code: LLZ)
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.