FDA 510(k)

Bladder Scanner Model: BVT02

Numéro K : K223448 · 2023-07-07

DemandeurXuzhou Kaixin Electronic Instrument Co., Ltd.

Date de décision2023-07-07

Code produitIYO

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

Bladder Scanner Model: BVT02 is the device name listed in this FDA 510(k) record. The listed applicant is Xuzhou Kaixin Electronic Instrument Co., Ltd.. It received FDA 510(k) clearance on 2023-07-07 under 510(k) number K223448. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Xuzhou Kaixin Electronic Instrument Co., Ltd.. The 510(k) number is K223448.

When did Bladder Scanner Model: BVT02 receive FDA 510(k) clearance?

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

Who is the listed applicant for Bladder Scanner Model: BVT02?

The FDA 510(k) record lists Xuzhou Kaixin Electronic Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Essais cliniques associés

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Dispositifs connexes (Code : IYO)

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApS K252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

Source officielle

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