FDA 510(k)

VIVA combo RF 系統（VIVA combo RF 系統）

K 號：K234140 · 2024-01-30

決定日期2024-01-30

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

VIVA combo RF System (VIVA combo RF System) is the device name listed in this FDA 510(k) record. The listed applicant is Starmed Co., Ltd.. It received FDA 510(k) clearance on 2024-01-30 under 510(k) number K234140. 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 VIVA combo RF System (VIVA combo RF System)?

VIVA combo RF System (VIVA combo RF System) is a medical device that received FDA 510(k) clearance on 2024-01-30. The listed applicant is Starmed Co., Ltd.. The 510(k) number is K234140.

When did VIVA combo RF System (VIVA combo RF System) receive FDA 510(k) clearance?

VIVA combo RF System (VIVA combo RF System) received FDA 510(k) clearance on 2024-01-30, under 510(k) number K234140.

Who is the listed applicant for VIVA combo RF System (VIVA combo RF System)?

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

What is the FDA product code for VIVA combo RF System (VIVA combo RF System)?

The FDA product code for VIVA combo RF System (VIVA combo RF System) is GEI.

其他以 Starmed Co., Ltd. 為申請人之記錄

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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

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