FDA 510(k)

HF1202H パワープラスポータブル X線装置

K番号: K153059 · 2016-02-02

決定日2016-02-02

製品コードIZL

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

HF1202H PowerPlus Portable X-ray Equipment is the device name listed in this FDA 510(k) record. The listed applicant is Minxray, Inc.. It received FDA 510(k) clearance on 2016-02-02 under 510(k) number K153059. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the HF1202H PowerPlus Portable X-ray Equipment?

HF1202H PowerPlus Portable X-ray Equipment is a medical device that received FDA 510(k) clearance on 2016-02-02. The listed applicant is Minxray, Inc.. The 510(k) number is K153059.

When did HF1202H PowerPlus Portable X-ray Equipment receive FDA 510(k) clearance?

HF1202H PowerPlus Portable X-ray Equipment received FDA 510(k) clearance on 2016-02-02, under 510(k) number K153059.

Who is the listed applicant for HF1202H PowerPlus Portable X-ray Equipment?

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

What is the FDA product code for HF1202H PowerPlus Portable X-ray Equipment?

The FDA product code for HF1202H PowerPlus Portable X-ray Equipment is IZL.

申請者としてMinxray, Inc.を記載するその他の記録

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