FDA 510(k)

耳壓舒緩設備（型號：ER813B）

K 號：K230502 · 2023-06-09

決定日期2023-06-09

產品代碼MJV

決定相當於

器材摘要

Ear Pressure Relief Device(Model:ER813B) is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Albert Novosino Co., Ltd.. It received FDA 510(k) clearance on 2023-06-09 under 510(k) number K230502. The device is classified under product code MJV. FDA Decision: Substantially Equivalent.

常見問題

What is the Ear Pressure Relief Device(Model:ER813B)?

Ear Pressure Relief Device(Model:ER813B) is a medical device that received FDA 510(k) clearance on 2023-06-09. The listed applicant is Ningbo Albert Novosino Co., Ltd.. The 510(k) number is K230502.

When did Ear Pressure Relief Device(Model:ER813B) receive FDA 510(k) clearance?

Ear Pressure Relief Device(Model:ER813B) received FDA 510(k) clearance on 2023-06-09, under 510(k) number K230502.

Who is the listed applicant for Ear Pressure Relief Device(Model:ER813B)?

The FDA 510(k) record lists Ningbo Albert Novosino Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ear Pressure Relief Device(Model:ER813B)?

The FDA product code for Ear Pressure Relief Device(Model:ER813B) is MJV.

其他以 Ningbo Albert Novosino Co., Ltd. 為申請人之記錄

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相關器械（代碼：MJV）

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。

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官方來源

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