FDA 510(k)

CEFALY Connected - OTC，CEFALY Connected - Rx

K号: K234029 · 2024-07-18

决定日期2024-07-18

产品代码PCC

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决定实质等同

器械摘要

CEFALY Connected - OTC, CEFALY Connected - Rx is the device name listed in this FDA 510(k) record. The listed applicant is Cefaly Technology. It received FDA 510(k) clearance on 2024-07-18 under 510(k) number K234029. The device is classified under product code PCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CEFALY Connected - OTC, CEFALY Connected - Rx?

CEFALY Connected - OTC, CEFALY Connected - Rx is a medical device that received FDA 510(k) clearance on 2024-07-18. The listed applicant is Cefaly Technology. The 510(k) number is K234029.

When did CEFALY Connected - OTC, CEFALY Connected - Rx receive FDA 510(k) clearance?

CEFALY Connected - OTC, CEFALY Connected - Rx received FDA 510(k) clearance on 2024-07-18, under 510(k) number K234029.

Who is the listed applicant for CEFALY Connected - OTC, CEFALY Connected - Rx?

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

What is the FDA product code for CEFALY Connected - OTC, CEFALY Connected - Rx?

The FDA product code for CEFALY Connected - OTC, CEFALY Connected - Rx is PCC.

列明Cefaly Technology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。

K212071Cefaly 双重增强型 RFID - OTC, Cefaly 双重增强型 RFID - 处方, Cefaly 双重连接 - OTC, Cefaly 双重连接 - 处方 K201895Cefaly 双重 K173006Cefaly 双重 K171446Cefaly 急性 K160237Cefaly

官方来源

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