FDA 510(k)

PIEZOTOME M+，PIEZOTOME M+ 手柄

K 號：K163610 · 2017-05-19

決定日期2017-05-19

產品代碼JDX

諮詢委員會或

決定相當於

器材摘要

PIEZOTOME M+, PIEZOTOME M+ Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Satalec-Acteon Group. It received FDA 510(k) clearance on 2017-05-19 under 510(k) number K163610. The device is classified under product code JDX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PIEZOTOME M+, PIEZOTOME M+ Handpiece?

PIEZOTOME M+, PIEZOTOME M+ Handpiece is a medical device that received FDA 510(k) clearance on 2017-05-19. The listed applicant is Satalec-Acteon Group. The 510(k) number is K163610.

When did PIEZOTOME M+, PIEZOTOME M+ Handpiece receive FDA 510(k) clearance?

PIEZOTOME M+, PIEZOTOME M+ Handpiece received FDA 510(k) clearance on 2017-05-19, under 510(k) number K163610.

Who is the listed applicant for PIEZOTOME M+, PIEZOTOME M+ Handpiece?

The FDA 510(k) record lists Satalec-Acteon Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PIEZOTOME M+, PIEZOTOME M+ Handpiece?

The FDA product code for PIEZOTOME M+, PIEZOTOME M+ Handpiece is JDX.

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K201274超音波骨切術系統Smtp Technology Co., Ltd.K172464XD880A 超聲骨切術術後系統Morley Research Consortium K153743PIEZOSURGERY PLUSMectron S.P.A.

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器材摘要

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