FDA 510(k)

FlowMet

K 號：K192966 · 2020-01-10

決定日期2020-01-10

產品代碼DPW

諮詢委員會履歷

決定相當於

器材摘要

FlowMet is the device name listed in this FDA 510(k) record. The listed applicant is Laser Associated Sciences, Inc.. It received FDA 510(k) clearance on 2020-01-10 under 510(k) number K192966. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FlowMet?

FlowMet is a medical device that received FDA 510(k) clearance on 2020-01-10. The listed applicant is Laser Associated Sciences, Inc.. The 510(k) number is K192966.

When did FlowMet receive FDA 510(k) clearance?

FlowMet received FDA 510(k) clearance on 2020-01-10, under 510(k) number K192966.

Who is the listed applicant for FlowMet?

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

What is the FDA product code for FlowMet?

The FDA product code for FlowMet is DPW.

其他以 Laser Associated Sciences, Inc. 為申請人之記錄

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。

K182494FlowMet-R

相關器械（代碼：DPW）

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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官方來源

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