INNOVANCE Free PS Ag
K 號：K181525 · 2018-09-07
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決定日期2018-09-07
產品代碼GGP
諮詢委員會HE
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決定相當於
器材摘要
INNOVANCE Free PS Ag is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2018-09-07 under 510(k) number K181525. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the INNOVANCE Free PS Ag?
INNOVANCE Free PS Ag is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K181525.
When did INNOVANCE Free PS Ag receive FDA 510(k) clearance?
INNOVANCE Free PS Ag received FDA 510(k) clearance on 2018-09-07, under 510(k) number K181525.
Who is the listed applicant for INNOVANCE Free PS Ag?
The FDA 510(k) record lists Siemens Healthcare Diagnostics Products GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for INNOVANCE Free PS Ag?
The FDA product code for INNOVANCE Free PS Ag is GGP.
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其他以 Siemens Healthcare Diagnostics Products GmbH 為申請人之記錄
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相關器械（代碼：GGP）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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