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FDA 510(k)

Kiierr 272 激光,Kiierr 148 激光

K 號:K181878 · 2018-09-05

決定日期2018-09-05
產品代碼OAP
諮詢委員會PM
決定相當於

器材摘要

Kiierr 272 Laser, Kiierr 148 Laser is the device name listed in this FDA 510(k) record. The listed applicant is Kiierr International, LLC. It received FDA 510(k) clearance on 2018-09-05 under 510(k) number K181878. 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 Kiierr 272 Laser, Kiierr 148 Laser?

Kiierr 272 Laser, Kiierr 148 Laser is a medical device that received FDA 510(k) clearance on 2018-09-05. The listed applicant is Kiierr International, LLC. The 510(k) number is K181878.

When did Kiierr 272 Laser, Kiierr 148 Laser receive FDA 510(k) clearance?

Kiierr 272 Laser, Kiierr 148 Laser received FDA 510(k) clearance on 2018-09-05, under 510(k) number K181878.

Who is the listed applicant for Kiierr 272 Laser, Kiierr 148 Laser?

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

What is the FDA product code for Kiierr 272 Laser, Kiierr 148 Laser?

The FDA product code for Kiierr 272 Laser, Kiierr 148 Laser 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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