MRI Universal
K-Number: K240651 · 2024-07-12
ApplicantStryker Leibinger GmbH & Co KG
Decision Date2024-07-12
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
MRI Universal is a medical device manufactured by Stryker Leibinger GmbH & Co KG. It received FDA 510(k) clearance on 2024-07-12 under approval number K240651. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MRI Universal?
MRI Universal is a medical device that received FDA 510(k) clearance on 2024-07-12. It is manufactured by Stryker Leibinger GmbH & Co KG. The 510(k) number is K240651.
When was MRI Universal approved by the FDA?
MRI Universal received FDA 510(k) clearance on 2024-07-12, under approval number K240651.
What company makes MRI Universal?
MRI Universal is manufactured by Stryker Leibinger GmbH & Co KG.
What is the FDA product code for MRI Universal?
The FDA product code for MRI Universal is JEY.
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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.