FDA 510(k)

耳鼻喉內視鏡及其附件

K 號：K214050 · 2022-07-01

申請人Medimaging Integrated Solution, Inc (Miis)

決定日期2022-07-01

產品代碼EOB

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

ENT Nasopharyngoscope and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Medimaging Integrated Solution, Inc (Miis). It received FDA 510(k) clearance on 2022-07-01 under 510(k) number K214050. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ENT Nasopharyngoscope and Accessories?

ENT Nasopharyngoscope and Accessories is a medical device that received FDA 510(k) clearance on 2022-07-01. The listed applicant is Medimaging Integrated Solution, Inc (Miis). The 510(k) number is K214050.

When did ENT Nasopharyngoscope and Accessories receive FDA 510(k) clearance?

ENT Nasopharyngoscope and Accessories received FDA 510(k) clearance on 2022-07-01, under 510(k) number K214050.

Who is the listed applicant for ENT Nasopharyngoscope and Accessories?

The FDA 510(k) record lists Medimaging Integrated Solution, Inc (Miis) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENT Nasopharyngoscope and Accessories?

The FDA product code for ENT Nasopharyngoscope and Accessories is EOB.

其他以 Medimaging Integrated Solution, Inc (Miis) 為申請人之記錄

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官方來源

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