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FDA 510(k)

頁面編寫器 TC20 心電圖儀,頁面編寫器 TC30 心電圖儀,頁面編寫器 TC50 心電圖儀,頁面編寫器 TC70 心電圖儀

K 號:K210560 · 2021-06-30

決定日期2021-06-30
產品代碼DPS
諮詢委員會履歷
決定相當於

器材摘要

Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems. It received FDA 510(k) clearance on 2021-06-30 under 510(k) number K210560. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph?

Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph is a medical device that received FDA 510(k) clearance on 2021-06-30. The listed applicant is Philips Medical Systems. The 510(k) number is K210560.

When did Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph receive FDA 510(k) clearance?

Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph received FDA 510(k) clearance on 2021-06-30, under 510(k) number K210560.

Who is the listed applicant for Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph?

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

What is the FDA product code for Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph?

The FDA product code for Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph is DPS.

相關臨床試驗

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其他以 Philips Medical Systems 為申請人之記錄

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相關器械(代碼:DPS)

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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