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FDA 510(k)

ALOKA UST-5280-5

K-Number: K002784 · 2000-09-20

ApplicantAloka Co., Ltd.
Decision Date2000-09-20
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ALOKA UST-5280-5 is the device name listed in this FDA 510(k) record. The listed applicant is Aloka Co., Ltd.. It received FDA 510(k) clearance on 2000-09-20 under 510(k) number K002784. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALOKA UST-5280-5?

ALOKA UST-5280-5 is a medical device that received FDA 510(k) clearance on 2000-09-20. The listed applicant is Aloka Co., Ltd.. The 510(k) number is K002784.

When did ALOKA UST-5280-5 receive FDA 510(k) clearance?

ALOKA UST-5280-5 received FDA 510(k) clearance on 2000-09-20, under 510(k) number K002784.

Who is the listed applicant for ALOKA UST-5280-5?

The FDA 510(k) record lists Aloka Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALOKA UST-5280-5?

The FDA product code for ALOKA UST-5280-5 is ITX.

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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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