FDA 510(k)

塞法利

K 號：K160237 · 2016-03-04

決定日期2016-03-04

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 is the device name listed in this FDA 510(k) record. The listed applicant is Cefaly Technology. It received FDA 510(k) clearance on 2016-03-04 under 510(k) number K160237. 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?

Cefaly is a medical device that received FDA 510(k) clearance on 2016-03-04. The listed applicant is Cefaly Technology. The 510(k) number is K160237.

When did Cefaly receive FDA 510(k) clearance?

Cefaly received FDA 510(k) clearance on 2016-03-04, under 510(k) number K160237.

Who is the listed applicant for Cefaly?

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?

The FDA product code for Cefaly 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。

K234029CEFALY 連接 - 非處方藥，CEFALY 連接 - 藥局處方 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

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.K234029CEFALY 連接 - 非處方藥，CEFALY 連接 - 藥局處方Cefaly Technology K232749DOOPANGYbrain, Inc.K233751米維爾（YPS-301BD）Soterix Medical, Inc.K230782TENS設備-HeadaTerm 2（型號：YF-HT2）Wat Medical Technology, Inc.

官方來源

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