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FDA 510(k)

StimOn™ 疼痛緩解系統 (GM2439)

K 號:K213802 · 2022-08-26

決定日期2022-08-26
產品代碼GZJ
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

StimOnTM Pain Relief System (GM2439) is the device name listed in this FDA 510(k) record. The listed applicant is Gimer Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-08-26 under 510(k) number K213802. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the StimOnTM Pain Relief System (GM2439)?

StimOnTM Pain Relief System (GM2439) is a medical device that received FDA 510(k) clearance on 2022-08-26. The listed applicant is Gimer Medical Co., Ltd.. The 510(k) number is K213802.

When did StimOnTM Pain Relief System (GM2439) receive FDA 510(k) clearance?

StimOnTM Pain Relief System (GM2439) received FDA 510(k) clearance on 2022-08-26, under 510(k) number K213802.

Who is the listed applicant for StimOnTM Pain Relief System (GM2439)?

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

What is the FDA product code for StimOnTM Pain Relief System (GM2439)?

The FDA product code for StimOnTM Pain Relief System (GM2439) is GZJ.

相關臨床試驗

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相關器械(代碼:GZJ)

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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