FDA 510(k)

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K 號：K181651 · 2018-10-12

決定日期2018-10-12

產品代碼JOW

諮詢委員會履歷

決定相當於

器材摘要

Radial Medical Compression System is the device name listed in this FDA 510(k) record. The listed applicant is Radial Medical, Inc.. It received FDA 510(k) clearance on 2018-10-12 under 510(k) number K181651. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Radial Medical Compression System?

Radial Medical Compression System is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is Radial Medical, Inc.. The 510(k) number is K181651.

When did Radial Medical Compression System receive FDA 510(k) clearance?

Radial Medical Compression System received FDA 510(k) clearance on 2018-10-12, under 510(k) number K181651.

Who is the listed applicant for Radial Medical Compression System?

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

What is the FDA product code for Radial Medical Compression System?

The FDA product code for Radial Medical Compression System is JOW.

其他以 Radial Medical, Inc. 為申請人之記錄

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K190976橫向醫療壓力系統

相關器械（代碼：JOW）

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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