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FDA 510(k)

Bladder Scanner

K-Number: K230986 · 2023-12-29

ApplicantAvantsonic Technology Co., Ltd.
Decision Date2023-12-29
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Bladder Scanner is a medical device manufactured by Avantsonic Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-12-29 under approval number K230986. 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?

Bladder Scanner is a medical device that received FDA 510(k) clearance on 2023-12-29. It is manufactured by Avantsonic Technology Co., Ltd.. The 510(k) number is K230986.

When was Bladder Scanner approved by the FDA?

Bladder Scanner received FDA 510(k) clearance on 2023-12-29, under approval number K230986.

What company makes Bladder Scanner?

Bladder Scanner is manufactured by Avantsonic Technology Co., Ltd..

What is the FDA product code for Bladder Scanner?

The FDA product code for Bladder Scanner is IYO.

Other Devices by Avantsonic Technology Co., Ltd.

K171528Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)

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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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