FDA 510(k)

皇冠HT

K 號：K242277 · 2024-10-01

決定日期2024-10-01

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

Crown HT is the device name listed in this FDA 510(k) record. The listed applicant is Sprintray, Inc.. It received FDA 510(k) clearance on 2024-10-01 under 510(k) number K242277. 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 Crown HT?

Crown HT is a medical device that received FDA 510(k) clearance on 2024-10-01. The listed applicant is Sprintray, Inc.. The 510(k) number is K242277.

When did Crown HT receive FDA 510(k) clearance?

Crown HT received FDA 510(k) clearance on 2024-10-01, under 510(k) number K242277.

Who is the listed applicant for Crown HT?

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 Crown HT?

The FDA product code for Crown HT is EBF.

其他以 Sprintray, Inc. 為申請人之記錄

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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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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官方來源

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