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FDA 510(k)

Bladder Scanner Model: BVT02

K-Number: K223448 · 2023-07-07

Decision Date2023-07-07
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Bladder Scanner Model: BVT02 is a medical device manufactured by Xuzhou Kaixin Electronic Instrument Co., Ltd.. It received FDA 510(k) clearance on 2023-07-07 under approval number K223448. 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: BVT02?

Bladder Scanner Model: BVT02 is a medical device that received FDA 510(k) clearance on 2023-07-07. It is manufactured by Xuzhou Kaixin Electronic Instrument Co., Ltd.. The 510(k) number is K223448.

When was Bladder Scanner Model: BVT02 approved by the FDA?

Bladder Scanner Model: BVT02 received FDA 510(k) clearance on 2023-07-07, under approval number K223448.

What company makes Bladder Scanner Model: BVT02?

Bladder Scanner Model: BVT02 is manufactured by Xuzhou Kaixin Electronic Instrument Co., Ltd..

What is the FDA product code for Bladder Scanner Model: BVT02?

The FDA product code for Bladder Scanner Model: BVT02 is IYO.

Related Clinical Trials

Related Devices (Code: IYO)

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.