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FDA 510(k)

Inessa 系統

K 號：K230545 · 2023-12-20

申請人Triple Jump Israel , Ltd.
決定日期2023-12-20
產品代碼QFG
諮詢委員會CH
決定相當於

器材摘要

Inessa System is the device name listed in this FDA 510(k) record. The listed applicant is Triple Jump Israel , Ltd.. It received FDA 510(k) clearance on 2023-12-20 under 510(k) number K230545. The device is classified under product code QFG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Inessa System?

Inessa System is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is Triple Jump Israel , Ltd.. The 510(k) number is K230545.

When did Inessa System receive FDA 510(k) clearance?

Inessa System received FDA 510(k) clearance on 2023-12-20, under 510(k) number K230545.

Who is the listed applicant for Inessa System?

The FDA 510(k) record lists Triple Jump Israel , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Inessa System?

The FDA product code for Inessa System is QFG.

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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相關器械（代碼：QFG）

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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