FDA 510(k)

N5-1 医療設備規範文本翻譯： N5-1 医療設備規範文

K 號：K153054 · 2016-02-05

決定日期2016-02-05

產品代碼JFB

諮詢委員會PM

決定相當於

器材摘要

N5-1 is the device name listed in this FDA 510(k) record. The listed applicant is Nuga Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-02-05 under 510(k) number K153054. The device is classified under product code JFB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the N5-1?

N5-1 is a medical device that received FDA 510(k) clearance on 2016-02-05. The listed applicant is Nuga Medical Co., Ltd.. The 510(k) number is K153054.

When did N5-1 receive FDA 510(k) clearance?

N5-1 received FDA 510(k) clearance on 2016-02-05, under 510(k) number K153054.

Who is the listed applicant for N5-1?

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

What is the FDA product code for N5-1?

The FDA product code for N5-1 is JFB.

其他以 Nuga Medical Co., Ltd. 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。

K240168N7-S

相關器械（代碼：JFB）

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。

K250266瓷療自動熱按摩器（CGM MB-2401）Ceragem Co., Ltd.K241193AGILIS - 多功能物理治療臺（型號：Plus，Pro和Basic）Marzzan Lucas Jorge K243644瓷療自動熱療按摩器（CGM MB-2301 & CGM MB-2302）Ceragem Co., Ltd.K243355瓷療自動熱按摩器（CGM-MB-1902）Ceragem Co., Ltd.K240168N7-SNuga Medical Co., Ltd.K220572瓷療自動熱療按摩器，型號 CGM MB-1701 及 CGM MB-1702Ceragem Co., Ltd.

官方來源

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