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FDA 510(k)

Glide (91000-GL-X)

K 號:K240884 · 2024-04-15

決定日期2024-04-15
產品代碼GXY
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

Glide (91000-GL-X) is the device name listed in this FDA 510(k) record. The listed applicant is Infinite Biomedical Technologies, LLC. It received FDA 510(k) clearance on 2024-04-15 under 510(k) number K240884. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Glide (91000-GL-X)?

Glide (91000-GL-X) is a medical device that received FDA 510(k) clearance on 2024-04-15. The listed applicant is Infinite Biomedical Technologies, LLC. The 510(k) number is K240884.

When did Glide (91000-GL-X) receive FDA 510(k) clearance?

Glide (91000-GL-X) received FDA 510(k) clearance on 2024-04-15, under 510(k) number K240884.

Who is the listed applicant for Glide (91000-GL-X)?

The FDA 510(k) record lists Infinite Biomedical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Glide (91000-GL-X)?

The FDA product code for Glide (91000-GL-X) is GXY.

相關臨床試驗

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其他以 Infinite Biomedical Technologies, LLC 為申請人之記錄

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相關器械(代碼:GXY)

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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