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FDA 510(k)

BladderScan Prime PLUS系统

K号: K172356 · 2017-09-15

决定日期2017-09-15
产品代码IYO
咨询委员会RA
决定实质等同

器械摘要

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.

常见问题

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.

相关临床试验

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相关器械(代码:IYO)

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