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FDA 510(k)

Cocoon 隨身手持式X光系統

K 號:K173046 · 2017-10-26

決定日期2017-10-26
產品代碼MUH
諮詢委員會DE
決定相當於

器材摘要

Cocoon Portable Handheld X-Ray System is the device name listed in this FDA 510(k) record. The listed applicant is Dexcowin Co., Ltd.. It received FDA 510(k) clearance on 2017-10-26 under 510(k) number K173046. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cocoon Portable Handheld X-Ray System?

Cocoon Portable Handheld X-Ray System is a medical device that received FDA 510(k) clearance on 2017-10-26. The listed applicant is Dexcowin Co., Ltd.. The 510(k) number is K173046.

When did Cocoon Portable Handheld X-Ray System receive FDA 510(k) clearance?

Cocoon Portable Handheld X-Ray System received FDA 510(k) clearance on 2017-10-26, under 510(k) number K173046.

Who is the listed applicant for Cocoon Portable Handheld X-Ray System?

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

What is the FDA product code for Cocoon Portable Handheld X-Ray System?

The FDA product code for Cocoon Portable Handheld X-Ray System is MUH.

相關臨床試驗

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相關器械(代碼:MUH)

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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