FDA 510(k)

MD-6000P Bladder Scanner

K-Number: K182460 · 2019-05-06

Decision Date2019-05-06

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MD-6000P Bladder Scanner is a medical device manufactured by MEDA Co., Ltd.. It received FDA 510(k) clearance on 2019-05-06 under approval number K182460. 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 MD-6000P Bladder Scanner?

MD-6000P Bladder Scanner is a medical device that received FDA 510(k) clearance on 2019-05-06. It is manufactured by MEDA Co., Ltd.. The 510(k) number is K182460.

When was MD-6000P Bladder Scanner approved by the FDA?

MD-6000P Bladder Scanner received FDA 510(k) clearance on 2019-05-06, under approval number K182460.

What company makes MD-6000P Bladder Scanner?

MD-6000P Bladder Scanner is manufactured by MEDA Co., Ltd..

What is the FDA product code for MD-6000P Bladder Scanner?

The FDA product code for MD-6000P Bladder Scanner is IYO.

Other Devices by MEDA Co., Ltd.

K213070MD-320W Ultrasound Biomicroscope

Related Devices (Code: IYO)

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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.