FDA 510(k)

CephSimulation

K 號：K161270 · 2017-01-04

決定日期2017-01-04

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

CephSimulation is the device name listed in this FDA 510(k) record. The listed applicant is Anatomage, Inc.. It received FDA 510(k) clearance on 2017-01-04 under 510(k) number K161270. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CephSimulation?

CephSimulation is a medical device that received FDA 510(k) clearance on 2017-01-04. The listed applicant is Anatomage, Inc.. The 510(k) number is K161270.

When did CephSimulation receive FDA 510(k) clearance?

CephSimulation received FDA 510(k) clearance on 2017-01-04, under 510(k) number K161270.

Who is the listed applicant for CephSimulation?

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

What is the FDA product code for CephSimulation?

The FDA product code for CephSimulation is LLZ.

其他以 Anatomage, Inc. 為申請人之記錄

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相關器械（代碼：LLZ）

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