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 the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Corporation Medical Systems Division. It received FDA 510(k) clearance on 2024-05-24 under 510(k) 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. The listed applicant is Shimadzu Corporation Medical Systems Division. The 510(k) number is K240827.

When did SET-5002 receive FDA 510(k) clearance?

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

Who is the listed applicant for SET-5002?

The FDA 510(k) record lists Shimadzu Corporation Medical Systems Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SET-5002?

The FDA product code for SET-5002 is KPS.

Other records listing Shimadzu Corporation Medical Systems Division 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.

K221922Trinias

Related Devices (Code: KPS)

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.