FDA 510(k)

Cardiart 電子聽診器型號 DS101 Omni-Steth 電子聽診器型號 Omni-Steth

K 號：K182196 · 2018-09-11

決定日期2018-09-11

產品代碼DQD

諮詢委員會履歷

決定相當於

器材摘要

Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth is the device name listed in this FDA 510(k) record. The listed applicant is Imediplus, Inc.. It received FDA 510(k) clearance on 2018-09-11 under 510(k) number K182196. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth?

Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth is a medical device that received FDA 510(k) clearance on 2018-09-11. The listed applicant is Imediplus, Inc.. The 510(k) number is K182196.

When did Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth receive FDA 510(k) clearance?

Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth received FDA 510(k) clearance on 2018-09-11, under 510(k) number K182196.

Who is the listed applicant for Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth?

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

What is the FDA product code for Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth?

The FDA product code for Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth is DQD.

其他以 Imediplus, 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。

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相關器械（代碼：DQD）

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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