FDA 510(k)

米達斯恢復

K 號：K260661 · 2026-04-15

決定日期2026-04-15

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

Midas Restore is the device name listed in this FDA 510(k) record. The listed applicant is Sprintray, Inc.. It received FDA 510(k) clearance on 2026-04-15 under 510(k) number K260661. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Midas Restore?

Midas Restore is a medical device that received FDA 510(k) clearance on 2026-04-15. The listed applicant is Sprintray, Inc.. The 510(k) number is K260661.

When did Midas Restore receive FDA 510(k) clearance?

Midas Restore received FDA 510(k) clearance on 2026-04-15, under 510(k) number K260661.

Who is the listed applicant for Midas Restore?

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

What is the FDA product code for Midas Restore?

The FDA product code for Midas Restore is EBF.

其他以 Sprintray, Inc. 為申請人之記錄

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相關器械（代碼：EBF）

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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