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FDA 510(k)

CURVE 激光系統

K 號:K170709 · 2017-06-06

決定日期2017-06-06
產品代碼OLI
諮詢委員會SU 請提供完整的描述文本,以便我進行翻譯。
決定相當於

器材摘要

CURVE Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Yolo Medical, Inc.. It received FDA 510(k) clearance on 2017-06-06 under 510(k) number K170709. The device is classified under product code OLI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CURVE Laser System?

CURVE Laser System is a medical device that received FDA 510(k) clearance on 2017-06-06. The listed applicant is Yolo Medical, Inc.. The 510(k) number is K170709.

When did CURVE Laser System receive FDA 510(k) clearance?

CURVE Laser System received FDA 510(k) clearance on 2017-06-06, under 510(k) number K170709.

Who is the listed applicant for CURVE Laser System?

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

What is the FDA product code for CURVE Laser System?

The FDA product code for CURVE Laser System is OLI.

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相關器械(代碼:OLI)

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。

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