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FDA 510(k)

Medaica M1 電子聽診器

K 號:K223166 · 2023-01-19

申請人Medaica, Inc.
決定日期2023-01-19
產品代碼DQD
諮詢委員會履歷
決定相當於

器材摘要

Medaica M1 Telehealth Stethoscope is the device name listed in this FDA 510(k) record. The listed applicant is Medaica, Inc.. It received FDA 510(k) clearance on 2023-01-19 under 510(k) number K223166. 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 Medaica M1 Telehealth Stethoscope?

Medaica M1 Telehealth Stethoscope is a medical device that received FDA 510(k) clearance on 2023-01-19. The listed applicant is Medaica, Inc.. The 510(k) number is K223166.

When did Medaica M1 Telehealth Stethoscope receive FDA 510(k) clearance?

Medaica M1 Telehealth Stethoscope received FDA 510(k) clearance on 2023-01-19, under 510(k) number K223166.

Who is the listed applicant for Medaica M1 Telehealth Stethoscope?

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

What is the FDA product code for Medaica M1 Telehealth Stethoscope?

The FDA product code for Medaica M1 Telehealth Stethoscope is DQD.

相關臨床試驗

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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。

官方來源

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