FDA 510(k)

HC脊椎系統

K 號：K151362 · 2016-05-05

決定日期2016-05-05

產品代碼MNH

諮詢委員會或

決定相當於

器材摘要

HC Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Hung Chun Bio-S Co., Ltd.. It received FDA 510(k) clearance on 2016-05-05 under 510(k) number K151362. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the HC Spinal System?

HC Spinal System is a medical device that received FDA 510(k) clearance on 2016-05-05. The listed applicant is Hung Chun Bio-S Co., Ltd.. The 510(k) number is K151362.

When did HC Spinal System receive FDA 510(k) clearance?

HC Spinal System received FDA 510(k) clearance on 2016-05-05, under 510(k) number K151362.

Who is the listed applicant for HC Spinal System?

The FDA 510(k) record lists Hung Chun Bio-S Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HC Spinal System?

The FDA product code for HC Spinal System is MNH. This falls under the ENT category.

其他以 Hung Chun Bio-S Co., Ltd. 為申請人之記錄

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