FDA 510(k)

mi-eye 3 眼鏡式內視鏡附針筒，mi-tablet 3

K 號：K212556 · 2021-09-15

決定日期2021-09-15

產品代碼HRX

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決定相當於

器材摘要

mi-eye 3 needlescope with cannula, mi-tablet 3 is the device name listed in this FDA 510(k) record. The listed applicant is Trice Medical, Inc.. It received FDA 510(k) clearance on 2021-09-15 under 510(k) number K212556. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the mi-eye 3 needlescope with cannula, mi-tablet 3?

mi-eye 3 needlescope with cannula, mi-tablet 3 is a medical device that received FDA 510(k) clearance on 2021-09-15. The listed applicant is Trice Medical, Inc.. The 510(k) number is K212556.

When did mi-eye 3 needlescope with cannula, mi-tablet 3 receive FDA 510(k) clearance?

mi-eye 3 needlescope with cannula, mi-tablet 3 received FDA 510(k) clearance on 2021-09-15, under 510(k) number K212556.

Who is the listed applicant for mi-eye 3 needlescope with cannula, mi-tablet 3?

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

What is the FDA product code for mi-eye 3 needlescope with cannula, mi-tablet 3?

The FDA product code for mi-eye 3 needlescope with cannula, mi-tablet 3 is HRX.

其他以 Trice Medical, Inc. 為申請人之記錄

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相關器械（代碼：HRX）

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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