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FDA 510(k)

模型 3543A、4343A、2929A 及 A843B

K 號:K170480 · 2017-07-07

決定日期2017-07-07
產品代碼MQB
諮詢委員會RA
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

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相關器械(代碼:MQB)

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

官方來源

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