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FDA 510(k)

Bladder Scanner

K-Number: K153581 · 2016-04-08

ApplicantCaresono Technology Co., Ltd.
Decision Date2016-04-08
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Bladder Scanner is a medical device manufactured by Caresono Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-04-08 under approval number K153581. 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 2016-04-08. It is manufactured by Caresono Technology Co., Ltd.. The 510(k) number is K153581.

When was Bladder Scanner approved by the FDA?

Bladder Scanner received FDA 510(k) clearance on 2016-04-08, under approval number K153581.

What company makes Bladder Scanner?

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

What is the FDA product code for Bladder Scanner?

The FDA product code for Bladder Scanner is IYO.

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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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