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FDA 510(k)

NTU-USB Ultrasound USB Box

K-Number: K173486 · 2018-07-11

Decision Date2018-07-11
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NTU-USB Ultrasound USB Box is a medical device manufactured by National Taiwan University. It received FDA 510(k) clearance on 2018-07-11 under approval number K173486. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NTU-USB Ultrasound USB Box?

NTU-USB Ultrasound USB Box is a medical device that received FDA 510(k) clearance on 2018-07-11. It is manufactured by National Taiwan University. The 510(k) number is K173486.

When was NTU-USB Ultrasound USB Box approved by the FDA?

NTU-USB Ultrasound USB Box received FDA 510(k) clearance on 2018-07-11, under approval number K173486.

What company makes NTU-USB Ultrasound USB Box?

NTU-USB Ultrasound USB Box is manufactured by National Taiwan University.

What is the FDA product code for NTU-USB Ultrasound USB Box?

The FDA product code for NTU-USB Ultrasound USB Box is IYN.

Related Devices (Code: IYN)

Official Source

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