FDA 510(k)

Aquarius 8600 1417TG および Aquarius 8600 1717TG

K番号: K171169 · 2017-10-12

決定日2017-10-12

製品コードMQB

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

Aquarius 8600 1417TG and Aquarius 8600 1717TG is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Dynamics Company , Ltd.. It received FDA 510(k) clearance on 2017-10-12 under 510(k) number K171169. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Aquarius 8600 1417TG and Aquarius 8600 1717TG?

Aquarius 8600 1417TG and Aquarius 8600 1717TG is a medical device that received FDA 510(k) clearance on 2017-10-12. The listed applicant is Imaging Dynamics Company , Ltd.. The 510(k) number is K171169.

When did Aquarius 8600 1417TG and Aquarius 8600 1717TG receive FDA 510(k) clearance?

Aquarius 8600 1417TG and Aquarius 8600 1717TG received FDA 510(k) clearance on 2017-10-12, under 510(k) number K171169.

Who is the listed applicant for Aquarius 8600 1417TG and Aquarius 8600 1717TG?

The FDA 510(k) record lists Imaging Dynamics Company , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aquarius 8600 1417TG and Aquarius 8600 1717TG?

The FDA product code for Aquarius 8600 1417TG and Aquarius 8600 1717TG is MQB.

申請者としてImaging Dynamics Company , Ltd.を記載するその他の記録

K173273Aquarius 8600 1417WCI；Aquarius 8600 1717WCI K171175Aquarius 8600 1417WC K170202Aquarius 8600

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