FDA 510(k)

ECT 棉質咬合塊-尺寸大，ECT 棉質咬合塊-尺寸中

K 號：K201309 · 2021-06-04

決定日期2021-06-04

產品代碼JXL

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium is the device name listed in this FDA 510(k) record. The listed applicant is Mecta Corporation. It received FDA 510(k) clearance on 2021-06-04 under 510(k) number K201309. The device is classified under product code JXL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium?

ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium is a medical device that received FDA 510(k) clearance on 2021-06-04. The listed applicant is Mecta Corporation. The 510(k) number is K201309.

When did ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium receive FDA 510(k) clearance?

ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium received FDA 510(k) clearance on 2021-06-04, under 510(k) number K201309.

Who is the listed applicant for ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium?

The FDA 510(k) record lists Mecta Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium?

The FDA product code for ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium is JXL.

其他以 Mecta Corporation 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。

K192834MECTA Sigma

相關器械（代碼：JXL）

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。

K221469PATI（舌傷防護器）Neurovice, LLC K172978SurgeoBiteSurgovations, LLC

官方來源

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