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FDA 510(k)

BenQ Diagnostic Ultrasound System

K-Number: K181313 · 2018-08-27

Decision Date2018-08-27
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BenQ Diagnostic Ultrasound System is a medical device manufactured by Qisda Corporation. It received FDA 510(k) clearance on 2018-08-27 under approval number K181313. 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 BenQ Diagnostic Ultrasound System?

BenQ Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2018-08-27. It is manufactured by Qisda Corporation. The 510(k) number is K181313.

When was BenQ Diagnostic Ultrasound System approved by the FDA?

BenQ Diagnostic Ultrasound System received FDA 510(k) clearance on 2018-08-27, under approval number K181313.

What company makes BenQ Diagnostic Ultrasound System?

BenQ Diagnostic Ultrasound System is manufactured by Qisda Corporation.

What is the FDA product code for BenQ Diagnostic Ultrasound System?

The FDA product code for BenQ Diagnostic Ultrasound System is IYN.

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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.