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FDA 510(k)

UST-5550-R; UST-5536-R; L43K

K-Number: K152126 · 2016-08-17

ApplicantHitachi Aloka Medical America, Inc.
Decision Date2016-08-17
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UST-5550-R; UST-5536-R; L43K is a medical device manufactured by Hitachi Aloka Medical America, Inc.. It received FDA 510(k) clearance on 2016-08-17 under approval number K152126. 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 UST-5550-R; UST-5536-R; L43K?

UST-5550-R; UST-5536-R; L43K is a medical device that received FDA 510(k) clearance on 2016-08-17. It is manufactured by Hitachi Aloka Medical America, Inc.. The 510(k) number is K152126.

When was UST-5550-R; UST-5536-R; L43K approved by the FDA?

UST-5550-R; UST-5536-R; L43K received FDA 510(k) clearance on 2016-08-17, under approval number K152126.

What company makes UST-5550-R; UST-5536-R; L43K?

UST-5550-R; UST-5536-R; L43K is manufactured by Hitachi Aloka Medical America, Inc..

What is the FDA product code for UST-5550-R; UST-5536-R; L43K?

The FDA product code for UST-5550-R; UST-5536-R; L43K is ITX.

Other Devices by Hitachi Aloka Medical America, Inc.

K153421HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS

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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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