FDA 510(k)

CAYMAN LP 板系統

K 號：K190584 · 2019-05-15

決定日期2019-05-15

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

CAYMAN LP Plate System is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2019-05-15 under 510(k) number K190584. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CAYMAN LP Plate System?

CAYMAN LP Plate System is a medical device that received FDA 510(k) clearance on 2019-05-15. The listed applicant is K2m, Inc.. The 510(k) number is K190584.

When did CAYMAN LP Plate System receive FDA 510(k) clearance?

CAYMAN LP Plate System received FDA 510(k) clearance on 2019-05-15, under 510(k) number K190584.

Who is the listed applicant for CAYMAN LP Plate System?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAYMAN LP Plate System?

The FDA product code for CAYMAN LP Plate System is KWQ.

其他以 K2m, Inc. 為申請人之記錄

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相關器械（代碼：KWQ）

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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