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FDA 510(k)

Bladder Scanner (Models: M2, M2-W, M1, M1-W)

K-Number: K190769 · 2019-05-22

Decision Date2019-05-22
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Bladder Scanner (Models: M2, M2-W, M1, M1-W) is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Lischka Medtech Co., Ltd.. It received FDA 510(k) clearance on 2019-05-22 under 510(k) number K190769. 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 (Models: M2, M2-W, M1, M1-W)?

Bladder Scanner (Models: M2, M2-W, M1, M1-W) is a medical device that received FDA 510(k) clearance on 2019-05-22. The listed applicant is Suzhou Lischka Medtech Co., Ltd.. The 510(k) number is K190769.

When did Bladder Scanner (Models: M2, M2-W, M1, M1-W) receive FDA 510(k) clearance?

Bladder Scanner (Models: M2, M2-W, M1, M1-W) received FDA 510(k) clearance on 2019-05-22, under 510(k) number K190769.

Who is the listed applicant for Bladder Scanner (Models: M2, M2-W, M1, M1-W)?

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

What is the FDA product code for Bladder Scanner (Models: M2, M2-W, M1, M1-W)?

The FDA product code for Bladder Scanner (Models: M2, M2-W, M1, M1-W) is IYO.

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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