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FDA 510(k)

托克體

K 號:K192039 · 2020-03-29

決定日期2020-03-29
產品代碼NGX
諮詢委員會PM
決定相當於

器材摘要

Torc Body is the device name listed in this FDA 510(k) record. The listed applicant is Johari Digital Healthcare Limited. It received FDA 510(k) clearance on 2020-03-29 under 510(k) number K192039. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Torc Body?

Torc Body is a medical device that received FDA 510(k) clearance on 2020-03-29. The listed applicant is Johari Digital Healthcare Limited. The 510(k) number is K192039.

When did Torc Body receive FDA 510(k) clearance?

Torc Body received FDA 510(k) clearance on 2020-03-29, under 510(k) number K192039.

Who is the listed applicant for Torc Body?

The FDA 510(k) record lists Johari Digital Healthcare Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Torc Body?

The FDA product code for Torc Body is NGX.

其他以 Johari Digital Healthcare Limited 為申請人之記錄

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相關器械(代碼:NGX)

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。

官方來源

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