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FDA 510(k)

SPY 隨身手持式影像 (SPY-PHI) 系統

K 號：K200737 · 2020-05-21

申請人Novadaq Technologies Ulc. (Now A Part of Stryker)
決定日期2020-05-21
產品代碼OWN
諮詢委員會GU
決定相當於

器材摘要

SPY Portable Handheld Imaging (SPY-PHI) System 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 2020-05-21 under 510(k) number K200737. 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 Portable Handheld Imaging (SPY-PHI) System?

SPY Portable Handheld Imaging (SPY-PHI) System is a medical device that received FDA 510(k) clearance on 2020-05-21. The listed applicant is Novadaq Technologies Ulc. (Now A Part of Stryker). The 510(k) number is K200737.

When did SPY Portable Handheld Imaging (SPY-PHI) System receive FDA 510(k) clearance?

SPY Portable Handheld Imaging (SPY-PHI) System received FDA 510(k) clearance on 2020-05-21, under 510(k) number K200737.

Who is the listed applicant for SPY Portable Handheld Imaging (SPY-PHI) System?

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 Portable Handheld Imaging (SPY-PHI) System?

The FDA product code for SPY Portable Handheld Imaging (SPY-PHI) System is OWN.

相關臨床試驗

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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）

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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