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FDA 510(k)

傷害cad手機版2.0

K 號:K160001 · 2016-02-12

決定日期2016-02-12
產品代碼LLZ
諮詢委員會RA
決定相當於

器材摘要

TraumaCad Mobile Release 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Voyant Health, Ltd.. It received FDA 510(k) clearance on 2016-02-12 under 510(k) number K160001. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TraumaCad Mobile Release 2.0?

TraumaCad Mobile Release 2.0 is a medical device that received FDA 510(k) clearance on 2016-02-12. The listed applicant is Voyant Health, Ltd.. The 510(k) number is K160001.

When did TraumaCad Mobile Release 2.0 receive FDA 510(k) clearance?

TraumaCad Mobile Release 2.0 received FDA 510(k) clearance on 2016-02-12, under 510(k) number K160001.

Who is the listed applicant for TraumaCad Mobile Release 2.0?

The FDA 510(k) record lists Voyant Health, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TraumaCad Mobile Release 2.0?

The FDA product code for TraumaCad Mobile Release 2.0 is LLZ.

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相關器械(代碼:LLZ)

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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