FDA 510(k)

CEFALY 連接 - 非處方藥，CEFALY 連接 - 藥局處方

K 號：K234029 · 2024-07-18

決定日期2024-07-18

產品代碼PCC

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

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.

常見問題

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.

其他以 Cefaly Technology 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。

K212071Cefaly雙效強化版配RFID - 非處方藥，Cefaly雙效強化版配RFID - 藥局處方，Cefaly雙連接版 - 非處方藥，Cefaly雙連接版 - 藥局處方 K201895Cefaly雙用版 K173006Cefaly雙用版 K171446Cefaly 急性 K160237塞法利

相關器械（代碼：PCC）

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。

K254216Enso 頭痛用藥品Hinge Health, Inc.K242719ELEXIR 2.0 (ALLIVE3)Nu Eyne Co., Ltd.K232749DOOPANGYbrain, Inc.K233751米維爾（YPS-301BD）Soterix Medical, Inc.K230782TENS設備-HeadaTerm 2（型號：YF-HT2）Wat Medical Technology, Inc.K212071Cefaly雙效強化版配RFID - 非處方藥，Cefaly雙效強化版配RFID - 藥局處方，Cefaly雙連接版 - 非處方藥，Cefaly雙連接版 - 藥局處方Cefaly Technology

官方來源

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