FDA 510(k)

EndoRotor 主控台，EndoRotor 球囊导管，EndoRotor 样本陷阱，EndoRotor 過濾組合，EndoRotor 滾筒架

K 號：K190715 · 2019-12-13

決定日期2019-12-13

產品代碼ERL

諮詢委員會中文(台灣): 此醫療設備之規範性文件遵循「醫療規範-v1」政策。以下為該文件之翻譯：此醫療設備已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的臨床試驗編號為NCTXXXXXXX，並在PubMed上以PMIDXXXXXXX登錄。該設備的識別碼為XXXXXXXX，相關資訊請參考以下網址：[URL]。公司名稱：[公司名稱] 產品名稱：[產品名稱]

決定相當於

器材摘要

EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand is the device name listed in this FDA 510(k) record. The listed applicant is Interscope, Inc.. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K190715. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand?

EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Interscope, Inc.. The 510(k) number is K190715.

When did EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand receive FDA 510(k) clearance?

EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand received FDA 510(k) clearance on 2019-12-13, under 510(k) number K190715.

Who is the listed applicant for EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand?

The FDA 510(k) record lists Interscope, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand?

The FDA product code for EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand is ERL.

其他以 Interscope, Inc. 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：ERL）

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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