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FDA 510(k)

Bladder Scanner, Model Name:M5

K-Number: K213488 · 2022-07-01

Decision Date2022-07-01
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Bladder Scanner, Model Name:M5 is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Peaksonic Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-01 under 510(k) 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. The listed applicant is Suzhou Peaksonic Medical Technology Co., Ltd.. The 510(k) number is K213488.

When did Bladder Scanner, Model Name:M5 receive FDA 510(k) clearance?

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

Who is the listed applicant for Bladder Scanner, Model Name:M5?

The FDA 510(k) record lists Suzhou Peaksonic Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Suzhou Peaksonic Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: IYO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.