FDA 510(k)

IQMインテグラルクオリティモニタ（もしくはIQM）

K番号: K162629 · 2016-10-20

決定日2016-10-20

製品コードIYE

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

IQM Integral Quality Monitor (also IQM) is the device name listed in this FDA 510(k) record. The listed applicant is Irt Systems. It received FDA 510(k) clearance on 2016-10-20 under 510(k) number K162629. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the IQM Integral Quality Monitor (also IQM)?

IQM Integral Quality Monitor (also IQM) is a medical device that received FDA 510(k) clearance on 2016-10-20. The listed applicant is Irt Systems. The 510(k) number is K162629.

When did IQM Integral Quality Monitor (also IQM) receive FDA 510(k) clearance?

IQM Integral Quality Monitor (also IQM) received FDA 510(k) clearance on 2016-10-20, under 510(k) number K162629.

Who is the listed applicant for IQM Integral Quality Monitor (also IQM)?

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

What is the FDA product code for IQM Integral Quality Monitor (also IQM)?

The FDA product code for IQM Integral Quality Monitor (also IQM) is IYE.

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IQMインテグラルクオリティモニタ（もしくはIQM）

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：IYE）

公式ソース