FDA 510(k)

TV-100

K 號：K173973 · 2018-07-20

決定日期2018-07-20

產品代碼CBK

諮詢委員會AN

決定相當於

器材摘要

TV-100 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Med Devices, Inc.. It received FDA 510(k) clearance on 2018-07-20 under 510(k) number K173973. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TV-100?

TV-100 is a medical device that received FDA 510(k) clearance on 2018-07-20. The listed applicant is Bio-Med Devices, Inc.. The 510(k) number is K173973.

When did TV-100 receive FDA 510(k) clearance?

TV-100 received FDA 510(k) clearance on 2018-07-20, under 510(k) number K173973.

Who is the listed applicant for TV-100?

The FDA 510(k) record lists Bio-Med Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TV-100?

The FDA product code for TV-100 is CBK.

其他以 Bio-Med Devices, Inc. 為申請人之記錄

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K213948氧氣監控器

相關器械（代碼：CBK）

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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