FDA 510(k)

SIRA 電外科設備

K 號：K181071 · 2019-01-16

決定日期2019-01-16

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

SIRA RFA Electrosurgical Device is the device name listed in this FDA 510(k) record. The listed applicant is Innoblative Designs, Inc.. It received FDA 510(k) clearance on 2019-01-16 under 510(k) number K181071. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SIRA RFA Electrosurgical Device?

SIRA RFA Electrosurgical Device is a medical device that received FDA 510(k) clearance on 2019-01-16. The listed applicant is Innoblative Designs, Inc.. The 510(k) number is K181071.

When did SIRA RFA Electrosurgical Device receive FDA 510(k) clearance?

SIRA RFA Electrosurgical Device received FDA 510(k) clearance on 2019-01-16, under 510(k) number K181071.

Who is the listed applicant for SIRA RFA Electrosurgical Device?

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

What is the FDA product code for SIRA RFA Electrosurgical Device?

The FDA product code for SIRA RFA Electrosurgical Device is GEI.

其他以 Innoblative Designs, Inc. 為申請人之記錄

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K232947SIRA™ RFA 電外科設備

相關器械（代碼：GEI）

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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