FDA 510(k)

RODIN 3D膠質支具，硬/柔

K 號：K231793 · 2024-03-26

決定日期2024-03-26

產品代碼MQC

決定相當於

器材摘要

RODIN 3D Resin SPLINT, Hard/Flex is the device name listed in this FDA 510(k) record. The listed applicant is Belport Company, Inc., Gingi-Pak. It received FDA 510(k) clearance on 2024-03-26 under 510(k) number K231793. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

常見問題

What is the RODIN 3D Resin SPLINT, Hard/Flex?

RODIN 3D Resin SPLINT, Hard/Flex is a medical device that received FDA 510(k) clearance on 2024-03-26. The listed applicant is Belport Company, Inc., Gingi-Pak. The 510(k) number is K231793.

When did RODIN 3D Resin SPLINT, Hard/Flex receive FDA 510(k) clearance?

RODIN 3D Resin SPLINT, Hard/Flex received FDA 510(k) clearance on 2024-03-26, under 510(k) number K231793.

Who is the listed applicant for RODIN 3D Resin SPLINT, Hard/Flex?

The FDA 510(k) record lists Belport Company, Inc., Gingi-Pak as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RODIN 3D Resin SPLINT, Hard/Flex?

The FDA product code for RODIN 3D Resin SPLINT, Hard/Flex is MQC.

其他以 Belport Company, Inc., Gingi-Pak 為申請人之記錄

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相關器械（代碼：MQC）

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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