FDA 510(k)

Ceragem 自动热疗按摩器 (CGM-MB-1902)

K号: K243355 · 2024-11-27

决定日期2024-11-27

产品代码JFB

咨询委员会PM 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

Ceragem Automatic Thermal Massager (CGM-MB-1902) is the device name listed in this FDA 510(k) record. The listed applicant is Ceragem Co., Ltd.. It received FDA 510(k) clearance on 2024-11-27 under 510(k) number K243355. 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 Ceragem Automatic Thermal Massager (CGM-MB-1902)?

Ceragem Automatic Thermal Massager (CGM-MB-1902) is a medical device that received FDA 510(k) clearance on 2024-11-27. The listed applicant is Ceragem Co., Ltd.. The 510(k) number is K243355.

When did Ceragem Automatic Thermal Massager (CGM-MB-1902) receive FDA 510(k) clearance?

Ceragem Automatic Thermal Massager (CGM-MB-1902) received FDA 510(k) clearance on 2024-11-27, under 510(k) number K243355.

Who is the listed applicant for Ceragem Automatic Thermal Massager (CGM-MB-1902)?

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

What is the FDA product code for Ceragem Automatic Thermal Massager (CGM-MB-1902)?

The FDA product code for Ceragem Automatic Thermal Massager (CGM-MB-1902) is JFB.

列明Ceragem 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。

K250266Ceragem 自动热疗按摩器 (CGM MB-2401)K243644Ceragem 自动热疗按摩器 (CGM MB-2301 & CGM MB-2302)K220572Ceragem 自动热疗按摩器，型号 CGM MB-1701 & CGM MB-1702 K202937Ceragem 自动热疗按摩器型号 CGM-MB-1701 & CGM-MB-1702 K202113Ceragem 自动热疗按摩器，型号 CGM-MB-1901

官方来源

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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。