FDA 510(k)

Palm Bladder Scanner - PBSV5.1

K-Number: K191307 · 2019-06-05

ApplicantMianyang Meike Electronic Equipment Co., Ltd.

Decision Date2019-06-05

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Palm Bladder Scanner - PBSV5.1 is a medical device manufactured by Mianyang Meike Electronic Equipment Co., Ltd.. It received FDA 510(k) clearance on 2019-06-05 under approval number K191307. 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 Palm Bladder Scanner - PBSV5.1?

Palm Bladder Scanner - PBSV5.1 is a medical device that received FDA 510(k) clearance on 2019-06-05. It is manufactured by Mianyang Meike Electronic Equipment Co., Ltd.. The 510(k) number is K191307.

When was Palm Bladder Scanner - PBSV5.1 approved by the FDA?

Palm Bladder Scanner - PBSV5.1 received FDA 510(k) clearance on 2019-06-05, under approval number K191307.

What company makes Palm Bladder Scanner - PBSV5.1?

Palm Bladder Scanner - PBSV5.1 is manufactured by Mianyang Meike Electronic Equipment Co., Ltd..

What is the FDA product code for Palm Bladder Scanner - PBSV5.1?

The FDA product code for Palm Bladder Scanner - PBSV5.1 is IYO.

Other Devices by Mianyang Meike Electronic Equipment Co., Ltd.

K210591Palm Bladder Scanner - PBSV7.1

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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.