FDA 510(k)

iovera系統

K 號：K173763 · 2018-02-28

決定日期2018-02-28

產品代碼GXH

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

iovera system is the device name listed in this FDA 510(k) record. The listed applicant is Myoscience, Inc.. It received FDA 510(k) clearance on 2018-02-28 under 510(k) number K173763. The device is classified under product code GXH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iovera system?

iovera system is a medical device that received FDA 510(k) clearance on 2018-02-28. The listed applicant is Myoscience, Inc.. The 510(k) number is K173763.

When did iovera system receive FDA 510(k) clearance?

iovera system received FDA 510(k) clearance on 2018-02-28, under 510(k) number K173763.

Who is the listed applicant for iovera system?

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

What is the FDA product code for iovera system?

The FDA product code for iovera system is GXH.

其他以 Myoscience, 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。

K161835iovera系統

相關器械（代碼：GXH）

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。

K250371cryoICE cryoXT 冷凍消融探針 (cryoXT)AtriCure, Inc.K243677iovera° 系統Pacira Biosciences, Inc.K243157AtriCure cryoICE BOX (ACM)AtriCure, Inc.K233170cryoICE cryoSPHERE+ 冷凍消融探針 (CRYOSP)；cryoICE cryoSPHERE+ 冷凍消融探針 (CRYOSP-L)；cryoICE cryoSPHERE MAX 冷凍消融探針 (CRYOSMAX)；cryoICE cryoSPHERE MAX 冷凍消融探針 (CRYOSMAX-L)AtriCure, Inc.K220656iovera 系統Pacira Biosciences, Inc.K211334Iovera 系統Pacira Pharmaceuticals, Inc.

官方來源

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