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FDA 510(k)

SET-5002

K-Number: K240827 · 2024-05-24

ApplicantShimadzu Corporation Medical Systems Division
Decision Date2024-05-24
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SET-5002 is a medical device manufactured by Shimadzu Corporation Medical Systems Division. It received FDA 510(k) clearance on 2024-05-24 under approval number K240827. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SET-5002?

SET-5002 is a medical device that received FDA 510(k) clearance on 2024-05-24. It is manufactured by Shimadzu Corporation Medical Systems Division. The 510(k) number is K240827.

When was SET-5002 approved by the FDA?

SET-5002 received FDA 510(k) clearance on 2024-05-24, under approval number K240827.

What company makes SET-5002?

SET-5002 is manufactured by Shimadzu Corporation Medical Systems Division.

What is the FDA product code for SET-5002?

The FDA product code for SET-5002 is KPS.

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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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