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FDA 510(k)

SPY-PHI 系統搭配 SPY-PHI 荧光評估軟體

K 號：K202244 · 2020-11-05

申請人Novadaq Technologies Ulc. (Now A Part of Stryker)
決定日期2020-11-05
產品代碼OWN
諮詢委員會GU
決定相當於

器材摘要

SPY-PHI System with SPY-PHI Fluorescence Assessment Software is the device name listed in this FDA 510(k) record. The listed applicant is Novadaq Technologies Ulc. (Now A Part of Stryker). It received FDA 510(k) clearance on 2020-11-05 under 510(k) number K202244. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SPY-PHI System with SPY-PHI Fluorescence Assessment Software?

SPY-PHI System with SPY-PHI Fluorescence Assessment Software is a medical device that received FDA 510(k) clearance on 2020-11-05. The listed applicant is Novadaq Technologies Ulc. (Now A Part of Stryker). The 510(k) number is K202244.

When did SPY-PHI System with SPY-PHI Fluorescence Assessment Software receive FDA 510(k) clearance?

SPY-PHI System with SPY-PHI Fluorescence Assessment Software received FDA 510(k) clearance on 2020-11-05, under 510(k) number K202244.

Who is the listed applicant for SPY-PHI System with SPY-PHI Fluorescence Assessment Software?

The FDA 510(k) record lists Novadaq Technologies Ulc. (Now A Part of Stryker) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPY-PHI System with SPY-PHI Fluorescence Assessment Software?

The FDA product code for SPY-PHI System with SPY-PHI Fluorescence Assessment Software is OWN.

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其他以 Novadaq Technologies Ulc. (Now A Part of Stryker) 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：OWN）

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