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FDA 510(k)

貝爾-賽菲爾 Pro

K 號:K163175 · 2017-03-20

決定日期2017-03-20
產品代碼MUH
諮詢委員會DE
決定相當於

器材摘要

Bel-Cypher Pro is the device name listed in this FDA 510(k) record. The listed applicant is Takara Belmont Corporation. It received FDA 510(k) clearance on 2017-03-20 under 510(k) number K163175. 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 Bel-Cypher Pro?

Bel-Cypher Pro is a medical device that received FDA 510(k) clearance on 2017-03-20. The listed applicant is Takara Belmont Corporation. The 510(k) number is K163175.

When did Bel-Cypher Pro receive FDA 510(k) clearance?

Bel-Cypher Pro received FDA 510(k) clearance on 2017-03-20, under 510(k) number K163175.

Who is the listed applicant for Bel-Cypher Pro?

The FDA 510(k) record lists Takara Belmont Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bel-Cypher Pro?

The FDA product code for Bel-Cypher Pro is MUH.

相關臨床試驗

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其他以 Takara Belmont Corporation 為申請人之記錄

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。

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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