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FDA 510(k)

智慧雷射梳

K 號:K213789 · 2022-06-24

決定日期2022-06-24
產品代碼OAP
諮詢委員會PM
決定相當於

器材摘要

Intelligence LaserComb is the device name listed in this FDA 510(k) record. The listed applicant is Yibin Yingtong Intelligent Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-06-24 under 510(k) number K213789. 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 Intelligence LaserComb?

Intelligence LaserComb is a medical device that received FDA 510(k) clearance on 2022-06-24. The listed applicant is Yibin Yingtong Intelligent Technology Co., Ltd.. The 510(k) number is K213789.

When did Intelligence LaserComb receive FDA 510(k) clearance?

Intelligence LaserComb received FDA 510(k) clearance on 2022-06-24, under 510(k) number K213789.

Who is the listed applicant for Intelligence LaserComb?

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

What is the FDA product code for Intelligence LaserComb?

The FDA product code for Intelligence LaserComb is OAP.

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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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