FDA 510(k)

BladderScan Prime PLUS System

K-Number: K172356 · 2017-09-15

Decision Date2017-09-15

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BladderScan Prime PLUS System is the device name listed in this FDA 510(k) record. The listed applicant is Verathon Incorporated. It received FDA 510(k) clearance on 2017-09-15 under 510(k) number K172356. 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 BladderScan Prime PLUS System?

BladderScan Prime PLUS System is a medical device that received FDA 510(k) clearance on 2017-09-15. The listed applicant is Verathon Incorporated. The 510(k) number is K172356.

When did BladderScan Prime PLUS System receive FDA 510(k) clearance?

BladderScan Prime PLUS System received FDA 510(k) clearance on 2017-09-15, under 510(k) number K172356.

Who is the listed applicant for BladderScan Prime PLUS System?

The FDA 510(k) record lists Verathon Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BladderScan Prime PLUS System?

The FDA product code for BladderScan Prime PLUS System is IYO.

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.