FDA 510(k)

恩可萊系統

K 號：K201238 · 2020-10-02

決定日期2020-10-02

產品代碼ORY

諮詢委員會DE

決定相當於

器材摘要

Encore System is the device name listed in this FDA 510(k) record. The listed applicant is Siesta Medical, Inc.. It received FDA 510(k) clearance on 2020-10-02 under 510(k) number K201238. The device is classified under product code ORY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Encore System?

Encore System is a medical device that received FDA 510(k) clearance on 2020-10-02. The listed applicant is Siesta Medical, Inc.. The 510(k) number is K201238.

When did Encore System receive FDA 510(k) clearance?

Encore System received FDA 510(k) clearance on 2020-10-02, under 510(k) number K201238.

Who is the listed applicant for Encore System?

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

What is the FDA product code for Encore System?

The FDA product code for Encore System is ORY.

其他以 Siesta Medical, Inc. 為申請人之記錄

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。

K213159恩可萊系統 K183310恩可萊系統

相關器械（代碼：ORY）

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。

K213159恩可萊系統Siesta Medical, Inc.K183310恩可萊系統Siesta Medical, Inc.

官方來源

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