FDA 510(k)

BHA100系列布蘭德潔淨聽力輔助器

K 號：K212609 · 2022-01-05

申請人Kaz USA, Inc., A Helen of Troy Company

決定日期2022-01-05

產品代碼QDD

諮詢委員會中文(台灣): 此醫療設備之規範性文件遵循「醫療規範-v1」政策。以下為該文件之翻譯：此醫療設備已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的臨床試驗編號為NCTXXXXXXX，並在PubMed上以PMIDXXXXXXX登錄。該設備的識別碼為XXXXXXXX，相關資訊請參考以下網址：[URL]。公司名稱：[公司名稱] 產品名稱：[產品名稱]

決定相當於

器材摘要

BHA100 Series Braun Clear Hearing Aid is the device name listed in this FDA 510(k) record. The listed applicant is Kaz USA, Inc., A Helen of Troy Company. It received FDA 510(k) clearance on 2022-01-05 under 510(k) number K212609. The device is classified under product code QDD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BHA100 Series Braun Clear Hearing Aid?

BHA100 Series Braun Clear Hearing Aid is a medical device that received FDA 510(k) clearance on 2022-01-05. The listed applicant is Kaz USA, Inc., A Helen of Troy Company. The 510(k) number is K212609.

When did BHA100 Series Braun Clear Hearing Aid receive FDA 510(k) clearance?

BHA100 Series Braun Clear Hearing Aid received FDA 510(k) clearance on 2022-01-05, under 510(k) number K212609.

Who is the listed applicant for BHA100 Series Braun Clear Hearing Aid?

The FDA 510(k) record lists Kaz USA, Inc., A Helen of Troy Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BHA100 Series Braun Clear Hearing Aid?

The FDA product code for BHA100 Series Braun Clear Hearing Aid is QDD.

其他以 Kaz USA, Inc., A Helen of Troy Company 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。

K193213維克斯 VNT200 非觸碰額頭體溫計 K180131維克斯快速讀數位體溫計 K181242布蘭德BNT400無觸碰+額頭溫度計 K181015布蘭德 BFH175 紅外線額頭溫度計 K163516布蘭德無觸碰+額頭NTF3000體溫計 K161933布蘭氏ThermoScan® 3 高速精準耳溫計

查看所有 8 項裝置 →

相關器械（代碼：QDD）

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。

K223911Lumen 155-SFIntricon Corporation K220403Vibe SF 自適應聽力輔助設備Wsaud A/S K220303MDHearingAid 聽力輔助應用程式，MDHearingAid 智能聽力輔助器Mdhearingaid K213424Jabra Enhance PlusGN Hearing A/S K211008Bose SoundControl 聽力輔助設備Bose Corporation

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。