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FDA 510(k)

SyMRI

K-Number: K233733 · 2024-03-26

ApplicantSyntheticmr AB (Publ.)
Decision Date2024-03-26
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SyMRI is a medical device manufactured by Syntheticmr AB (Publ.). It received FDA 510(k) clearance on 2024-03-26 under approval number K233733. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SyMRI?

SyMRI is a medical device that received FDA 510(k) clearance on 2024-03-26. It is manufactured by Syntheticmr AB (Publ.). The 510(k) number is K233733.

When was SyMRI approved by the FDA?

SyMRI received FDA 510(k) clearance on 2024-03-26, under approval number K233733.

What company makes SyMRI?

SyMRI is manufactured by Syntheticmr AB (Publ.).

What is the FDA product code for SyMRI?

The FDA product code for SyMRI is LNH.

Other Devices by Syntheticmr AB (Publ.)

K242524SyMRI

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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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