N5-1
K号: K153054 · 2016-02-05
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决定日期2016-02-05
产品代码JFB
咨询委员会PM
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决定实质等同
器械摘要
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.
常见问题
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.
列明Nuga Medical Co., Ltd.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：JFB）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K250266Ceragem 自动热疗按摩器 (CGM MB-2401)Ceragem Co., Ltd.K241193AGILIS - 多功能物理治疗床（型号：Plus，Pro和Basic）Marzzan Lucas JorgeK243644Ceragem 自动热疗按摩器 (CGM MB-2301 & CGM MB-2302)Ceragem Co., Ltd.K243355Ceragem 自动热疗按摩器 (CGM-MB-1902)Ceragem Co., Ltd.K240168N7-SNuga Medical Co., Ltd.K220572Ceragem 自动热疗按摩器，型号 CGM MB-1701 & CGM MB-1702Ceragem Co., Ltd.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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