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FDA 510(k)

Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)

K-Number: K171528 · 2018-01-24

ApplicantAvantsonic Technology Co., Ltd.
Decision Date2018-01-24
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) is a medical device manufactured by Avantsonic Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-01-24 under approval number K171528. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)?

Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) is a medical device that received FDA 510(k) clearance on 2018-01-24. It is manufactured by Avantsonic Technology Co., Ltd.. The 510(k) number is K171528.

When was Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) approved by the FDA?

Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) received FDA 510(k) clearance on 2018-01-24, under approval number K171528.

What company makes Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)?

Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) is manufactured by Avantsonic Technology Co., Ltd..

What is the FDA product code for Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)?

The FDA product code for Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) is IYO.

Related Clinical Trials

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Other Devices by Avantsonic Technology Co., Ltd.

K230986Bladder Scanner

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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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