FDA 510(k)Reprocessed Orbiter ST Steerable Diagnostic EP Catheter
K 號：K161393 · 2016-10-26
決定日期2016-10-26
產品代碼NLH
諮詢委員會CV
決定Substantially Equivalent
器材摘要
Reprocessed Orbiter ST Steerable Diagnostic EP Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health, LLC. It received FDA 510(k) clearance on 2016-10-26 under 510(k) number K161393. The device is classified under product code NLH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Reprocessed Orbiter ST Steerable Diagnostic EP Catheter?
Reprocessed Orbiter ST Steerable Diagnostic EP Catheter is a medical device that received FDA 510(k) clearance on 2016-10-26. The listed applicant is Innovative Health, LLC. The 510(k) number is K161393.
When did Reprocessed Orbiter ST Steerable Diagnostic EP Catheter receive FDA 510(k) clearance?
Reprocessed Orbiter ST Steerable Diagnostic EP Catheter received FDA 510(k) clearance on 2016-10-26, under 510(k) number K161393.
Who is the listed applicant for Reprocessed Orbiter ST Steerable Diagnostic EP Catheter?
The FDA 510(k) record lists Innovative Health, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Reprocessed Orbiter ST Steerable Diagnostic EP Catheter?
The FDA product code for Reprocessed Orbiter ST Steerable Diagnostic EP Catheter is NLH.
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其他以 Innovative Health, LLC 為申請人之記錄
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相關器械（代碼：NLH）
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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