FDA 510(k)

SPiN 胸部導航系統

K 號：K170023 · 2017-05-15

決定日期2017-05-15

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

SPiN Thoracic Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Veran Medical Technologies, Inc.. It received FDA 510(k) clearance on 2017-05-15 under 510(k) number K170023. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SPiN Thoracic Navigation System?

SPiN Thoracic Navigation System is a medical device that received FDA 510(k) clearance on 2017-05-15. The listed applicant is Veran Medical Technologies, Inc.. The 510(k) number is K170023.

When did SPiN Thoracic Navigation System receive FDA 510(k) clearance?

SPiN Thoracic Navigation System received FDA 510(k) clearance on 2017-05-15, under 510(k) number K170023.

Who is the listed applicant for SPiN Thoracic Navigation System?

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

What is the FDA product code for SPiN Thoracic Navigation System?

The FDA product code for SPiN Thoracic Navigation System is JAK.

其他以 Veran Medical Technologies, 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。

K202346SPiN視覺內視鏡視管系統

相關器械（代碼：JAK）

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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