FDA 510(k)

診斷用固定式電生理導管、診斷用電生理纜線

K 號：K183649 · 2019-06-07

決定日期2019-06-07

產品代碼DRF

諮詢委員會履歷

決定相當於

器材摘要

Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2019-06-07 under 510(k) number K183649. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable?

Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable is a medical device that received FDA 510(k) clearance on 2019-06-07. The listed applicant is Baylis Medical Company, Inc.. The 510(k) number is K183649.

When did Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable receive FDA 510(k) clearance?

Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable received FDA 510(k) clearance on 2019-06-07, under 510(k) number K183649.

Who is the listed applicant for Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable?

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

What is the FDA product code for Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable?

The FDA product code for Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable is DRF.

其他以 Baylis Medical Company, Inc. 為申請人之記錄

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相關器械（代碼：DRF）

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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