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FDA 510(k)

Magma Spark Pro (Magma Spark Plus, Alpha)

K 號：K183307 · 2018-12-11

申請人Formatk Systems , Ltd.
決定日期2018-12-11
產品代碼GEX
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

Magma Spark Pro (Magma Spark Plus, Alpha) is the device name listed in this FDA 510(k) record. The listed applicant is Formatk Systems , Ltd.. It received FDA 510(k) clearance on 2018-12-11 under 510(k) number K183307. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Magma Spark Pro (Magma Spark Plus, Alpha)?

Magma Spark Pro (Magma Spark Plus, Alpha) is a medical device that received FDA 510(k) clearance on 2018-12-11. The listed applicant is Formatk Systems , Ltd.. The 510(k) number is K183307.

When did Magma Spark Pro (Magma Spark Plus, Alpha) receive FDA 510(k) clearance?

Magma Spark Pro (Magma Spark Plus, Alpha) received FDA 510(k) clearance on 2018-12-11, under 510(k) number K183307.

Who is the listed applicant for Magma Spark Pro (Magma Spark Plus, Alpha)?

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

What is the FDA product code for Magma Spark Pro (Magma Spark Plus, Alpha)?

The FDA product code for Magma Spark Pro (Magma Spark Plus, Alpha) is GEX. This falls under the Gastroenterology category.

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其他以 Formatk Systems , Ltd. 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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