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 the device name listed in this FDA 510(k) record. The listed applicant is National Taiwan University. It received FDA 510(k) clearance on 2018-07-11 under 510(k) 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. The listed applicant is National Taiwan University. The 510(k) number is K173486.

When did NTU-USB Ultrasound USB Box receive FDA 510(k) clearance?

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

Who is the listed applicant for NTU-USB Ultrasound USB Box?

The FDA 510(k) record lists National Taiwan University as the applicant. This does not by itself establish the device manufacturer.

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)

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.

Official Source

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