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FDA 510(k)

Bladder Scanner, Model Name:M5

K-Number: K213488 · 2022-07-01

ApplicantSuzhou Peaksonic Medical Technology Co., Ltd.
Decision Date2022-07-01
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Bladder Scanner, Model Name:M5 is a medical device manufactured by Suzhou Peaksonic Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-01 under approval number K213488. 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 Name:M5?

Bladder Scanner, Model Name:M5 is a medical device that received FDA 510(k) clearance on 2022-07-01. It is manufactured by Suzhou Peaksonic Medical Technology Co., Ltd.. The 510(k) number is K213488.

When was Bladder Scanner, Model Name:M5 approved by the FDA?

Bladder Scanner, Model Name:M5 received FDA 510(k) clearance on 2022-07-01, under approval number K213488.

What company makes Bladder Scanner, Model Name:M5?

Bladder Scanner, Model Name:M5 is manufactured by Suzhou Peaksonic Medical Technology Co., Ltd..

What is the FDA product code for Bladder Scanner, Model Name:M5?

The FDA product code for Bladder Scanner, Model Name:M5 is IYO.

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Other Devices by Suzhou Peaksonic Medical Technology Co., Ltd.

K201316Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)

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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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