FDA 510(k)

モデル3543A、4343A、2929AおよびA843B

K番号: K170480 · 2017-07-07

申請者Shanghai PZ Medical Technolgoy Co., Ltd.

決定日2017-07-07

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

Models 3543A, 4343A, 2929A and A843B is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai PZ Medical Technolgoy Co., Ltd.. It received FDA 510(k) clearance on 2017-07-07 under 510(k) number K170480. 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 Models 3543A, 4343A, 2929A and A843B?

Models 3543A, 4343A, 2929A and A843B is a medical device that received FDA 510(k) clearance on 2017-07-07. The listed applicant is Shanghai PZ Medical Technolgoy Co., Ltd.. The 510(k) number is K170480.

When did Models 3543A, 4343A, 2929A and A843B receive FDA 510(k) clearance?

Models 3543A, 4343A, 2929A and A843B received FDA 510(k) clearance on 2017-07-07, under 510(k) number K170480.

Who is the listed applicant for Models 3543A, 4343A, 2929A and A843B?

The FDA 510(k) record lists Shanghai PZ Medical Technolgoy Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Models 3543A, 4343A, 2929A and A843B?

The FDA product code for Models 3543A, 4343A, 2929A and A843B is MQB.

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。

モデル3543A、4343A、2929AおよびA843B

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：MQB）

公式ソース