FDA 510(k)

ELAN 4 電機系統

K 號：K203739 · 2021-08-24

決定日期2021-08-24

產品代碼HBE

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

ELAN 4 Electro Motor System is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2021-08-24 under 510(k) number K203739. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ELAN 4 Electro Motor System?

ELAN 4 Electro Motor System is a medical device that received FDA 510(k) clearance on 2021-08-24. The listed applicant is Aesculap, Inc.. The 510(k) number is K203739.

When did ELAN 4 Electro Motor System receive FDA 510(k) clearance?

ELAN 4 Electro Motor System received FDA 510(k) clearance on 2021-08-24, under 510(k) number K203739.

Who is the listed applicant for ELAN 4 Electro Motor System?

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

What is the FDA product code for ELAN 4 Electro Motor System?

The FDA product code for ELAN 4 Electro Motor System is HBE.

其他以 Aesculap, Inc. 為申請人之記錄

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相關器械（代碼：HBE）

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官方來源

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