TGS導絲及更新版Scopis軟體
K 號：K193118 · 2020-02-21
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器材摘要
TGS Guidewire and updated Scopis Software is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Ent. It received FDA 510(k) clearance on 2020-02-21 under 510(k) number K193118. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the TGS Guidewire and updated Scopis Software?
TGS Guidewire and updated Scopis Software is a medical device that received FDA 510(k) clearance on 2020-02-21. The listed applicant is Stryker Ent. The 510(k) number is K193118.
When did TGS Guidewire and updated Scopis Software receive FDA 510(k) clearance?
TGS Guidewire and updated Scopis Software received FDA 510(k) clearance on 2020-02-21, under 510(k) number K193118.
Who is the listed applicant for TGS Guidewire and updated Scopis Software?
The FDA 510(k) record lists Stryker Ent as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TGS Guidewire and updated Scopis Software?
The FDA product code for TGS Guidewire and updated Scopis Software is PGW.
相關臨床試驗
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其他以 Stryker Ent 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。
相關器械（代碼：PGW）
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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