FDA 510(k)

Ponto骨锚式聽力系統

K 號：K152820 · 2016-01-22

決定日期2016-01-22

產品代碼MAH

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

Ponto Bone Anchored Hearing System is the device name listed in this FDA 510(k) record. The listed applicant is Oticon Medical AB. It received FDA 510(k) clearance on 2016-01-22 under 510(k) number K152820. The device is classified under product code MAH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ponto Bone Anchored Hearing System?

Ponto Bone Anchored Hearing System is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is Oticon Medical AB. The 510(k) number is K152820.

When did Ponto Bone Anchored Hearing System receive FDA 510(k) clearance?

Ponto Bone Anchored Hearing System received FDA 510(k) clearance on 2016-01-22, under 510(k) number K152820.

Who is the listed applicant for Ponto Bone Anchored Hearing System?

FDA 510(k) 記錄將 Oticon Medical AB 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Ponto Bone Anchored Hearing System?

The FDA product code for Ponto Bone Anchored Hearing System is MAH.

其他以 Oticon Medical AB 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。

K261142Ponto 5 Mini；Ponto 5 Superpower K240614Sentio Ti 套件；Sentio 1 Mini；Genie Medical BAHS K213733Ponto 5 超強版 K211640Ponto 5 Mini K203807Ponto骨锚式聽力系統，單耳手術套件 K190540Ponto 4

查看所有 8 項裝置 →

相關器械（代碼：MAH）

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。

K261142Ponto 5 Mini；Ponto 5 SuperpowerOticon Medical AB K203807Ponto骨锚式聽力系統，單耳手術套件Oticon Medical AB K182116BA310 牙槽，BIA310 假體/牙槽Cochlear Americas

官方來源

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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。