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FDA 510(k)

Stealth 系統、Stealth 感測器、Stealth 智能線材、StealthView 軟體

K 號：K162503 · 2017-03-24

申請人Cardiac Insight, Inc.
決定日期2017-03-24
產品代碼DSH
諮詢委員會履歷
決定相當於

器材摘要

Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Insight, Inc.. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K162503. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software?

Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Cardiac Insight, Inc.. The 510(k) number is K162503.

When did Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software receive FDA 510(k) clearance?

Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software received FDA 510(k) clearance on 2017-03-24, under 510(k) number K162503.

Who is the listed applicant for Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software?

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

What is the FDA product code for Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software?

The FDA product code for Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software is DSH.

相關臨床試驗

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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