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FDA 510(k)

Capillus 112, Capillus 244

K 號:K192012 · 2019-09-12

申請人Capillus
決定日期2019-09-12
產品代碼OAP
諮詢委員會PM
決定相當於

器材摘要

Capillus 112, Capillus 244 is the device name listed in this FDA 510(k) record. The listed applicant is Capillus. It received FDA 510(k) clearance on 2019-09-12 under 510(k) number K192012. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Capillus 112, Capillus 244?

Capillus 112, Capillus 244 is a medical device that received FDA 510(k) clearance on 2019-09-12. The listed applicant is Capillus. The 510(k) number is K192012.

When did Capillus 112, Capillus 244 receive FDA 510(k) clearance?

Capillus 112, Capillus 244 received FDA 510(k) clearance on 2019-09-12, under 510(k) number K192012.

Who is the listed applicant for Capillus 112, Capillus 244?

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

What is the FDA product code for Capillus 112, Capillus 244?

The FDA product code for Capillus 112, Capillus 244 is OAP.

相關臨床試驗

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相關器械(代碼:OAP)

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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