FDA 510(k)

色ドップラー超音波システム；モデル：mEye1およびmEye2

K番号: K182165 · 2018-12-20

申請者Shenzhen Well.D Medical Electronics Co., Ltd.

決定日2018-12-20

製品コードIYN

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

Color Doppler Ultrasound System; Model: mEye1 and mEye2 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Well.D Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2018-12-20 under 510(k) number K182165. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Color Doppler Ultrasound System; Model: mEye1 and mEye2?

Color Doppler Ultrasound System; Model: mEye1 and mEye2 is a medical device that received FDA 510(k) clearance on 2018-12-20. The listed applicant is Shenzhen Well.D Medical Electronics Co., Ltd.. The 510(k) number is K182165.

When did Color Doppler Ultrasound System; Model: mEye1 and mEye2 receive FDA 510(k) clearance?

Color Doppler Ultrasound System; Model: mEye1 and mEye2 received FDA 510(k) clearance on 2018-12-20, under 510(k) number K182165.

Who is the listed applicant for Color Doppler Ultrasound System; Model: mEye1 and mEye2?

The FDA 510(k) record lists Shenzhen Well.D Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Color Doppler Ultrasound System; Model: mEye1 and mEye2?

The FDA product code for Color Doppler Ultrasound System; Model: mEye1 and mEye2 is IYN.

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色ドップラー超音波システム；モデル：mEye1およびmEye2

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：IYN）

公式ソース