FDA 510(k)

精準治療系統；Synergy平台；Synergy；Infinity；VersaHD

K 號：K182138 · 2018-09-05

決定日期2018-09-05

產品代碼IYE

諮詢委員會RA

決定相當於

器材摘要

Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD is the device name listed in this FDA 510(k) record. The listed applicant is Eleckta Limited. It received FDA 510(k) clearance on 2018-09-05 under 510(k) number K182138. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD?

Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD is a medical device that received FDA 510(k) clearance on 2018-09-05. The listed applicant is Eleckta Limited. The 510(k) number is K182138.

When did Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD receive FDA 510(k) clearance?

Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD received FDA 510(k) clearance on 2018-09-05, under 510(k) number K182138.

Who is the listed applicant for Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD?

The FDA 510(k) record lists Eleckta Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD?

The FDA product code for Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD is IYE.

相關器械（代碼：IYE）

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官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：IYE）

官方來源