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FDA 510(k)

SAC2 - 電極膚膏

K 號:K192606 · 2020-01-17

決定日期2020-01-17
產品代碼GYB
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

SAC2 - Electrode Cream is the device name listed in this FDA 510(k) record. The listed applicant is Spes Medica Srl. It received FDA 510(k) clearance on 2020-01-17 under 510(k) number K192606. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SAC2 - Electrode Cream?

SAC2 - Electrode Cream is a medical device that received FDA 510(k) clearance on 2020-01-17. The listed applicant is Spes Medica Srl. The 510(k) number is K192606.

When did SAC2 - Electrode Cream receive FDA 510(k) clearance?

SAC2 - Electrode Cream received FDA 510(k) clearance on 2020-01-17, under 510(k) number K192606.

Who is the listed applicant for SAC2 - Electrode Cream?

The FDA 510(k) record lists Spes Medica Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAC2 - Electrode Cream?

The FDA product code for SAC2 - Electrode Cream is GYB.

相關臨床試驗

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其他以 Spes Medica Srl 為申請人之記錄

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相關器械(代碼:GYB)

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。

官方來源

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