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FDA 510(k)

Accurett

K 號：K161615 · 2016-08-23

申請人H&O Equipments, Nv/Sa
決定日期2016-08-23
產品代碼GEH
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

Accurett is the device name listed in this FDA 510(k) record. The listed applicant is H&O Equipments, Nv/Sa. It received FDA 510(k) clearance on 2016-08-23 under 510(k) number K161615. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Accurett?

Accurett is a medical device that received FDA 510(k) clearance on 2016-08-23. The listed applicant is H&O Equipments, Nv/Sa. The 510(k) number is K161615.

When did Accurett receive FDA 510(k) clearance?

Accurett received FDA 510(k) clearance on 2016-08-23, under 510(k) number K161615.

Who is the listed applicant for Accurett?

The FDA 510(k) record lists H&O Equipments, Nv/Sa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Accurett?

The FDA product code for Accurett is GEH.

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官方來源

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