FDA 510(k)

Apex 柔軟

K 號：K250617 · 2025-04-29

決定日期2025-04-29

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

Apex Flex is the device name listed in this FDA 510(k) record. The listed applicant is Sprintray, Inc.. It received FDA 510(k) clearance on 2025-04-29 under 510(k) number K250617. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Apex Flex?

Apex Flex is a medical device that received FDA 510(k) clearance on 2025-04-29. The listed applicant is Sprintray, Inc.. The 510(k) number is K250617.

When did Apex Flex receive FDA 510(k) clearance?

Apex Flex received FDA 510(k) clearance on 2025-04-29, under 510(k) number K250617.

Who is the listed applicant for Apex Flex?

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 Apex Flex?

The FDA product code for Apex Flex is EBI.

其他以 Sprintray, Inc. 為申請人之記錄

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K260661米達斯恢復 K242559數位體溫計 K242277皇冠HT K230445OnX 頑固 K222623數位皇冠 K221678SprintRay 高影響力牙托基座

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相關器械（代碼：EBI）

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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官方來源

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