FDA 510(k)

核心運動設備

K 號：K220081 · 2022-09-28

決定日期2022-09-28

產品代碼OTJ

諮詢委員會GU

決定相當於

器材摘要

CORE-SPORT is the device name listed in this FDA 510(k) record. The listed applicant is Incore Co., Ltd.. It received FDA 510(k) clearance on 2022-09-28 under 510(k) number K220081. The device is classified under product code OTJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CORE-SPORT?

CORE-SPORT is a medical device that received FDA 510(k) clearance on 2022-09-28. The listed applicant is Incore Co., Ltd.. The 510(k) number is K220081.

When did CORE-SPORT receive FDA 510(k) clearance?

CORE-SPORT received FDA 510(k) clearance on 2022-09-28, under 510(k) number K220081.

Who is the listed applicant for CORE-SPORT?

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

What is the FDA product code for CORE-SPORT?

The FDA product code for CORE-SPORT is OTJ.

其他以 Incore Co., Ltd. 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。

K232216Hemoblock_S（藥品）；Hemoblock_S（OTC）K221054核心注射器 K220846核心-SNARE K213338核心-剪接 K211148核心-套管刀

相關器械（代碼：OTJ）

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。

K232062單端口Dalim Medical Corp.K202688AFS醫療無菌單次使用進入端口系統Afs Medical Co. , Ltd.K160797FMX314 外科平台Fortimedix Surgical B.V.K152598終端保護者Nelis

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。