FDA 510(k)

咬斷兩個

K 號：K250047 · 2025-09-12

決定日期2025-09-12

產品代碼IRT

諮詢委員會PM

決定相當於

器材摘要

bite away two is the device name listed in this FDA 510(k) record. The listed applicant is mibeTec GmbH. It received FDA 510(k) clearance on 2025-09-12 under 510(k) number K250047. The device is classified under product code IRT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the bite away two?

bite away two is a medical device that received FDA 510(k) clearance on 2025-09-12. The listed applicant is mibeTec GmbH. The 510(k) number is K250047.

When did bite away two receive FDA 510(k) clearance?

bite away two received FDA 510(k) clearance on 2025-09-12, under 510(k) number K250047.

Who is the listed applicant for bite away two?

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

What is the FDA product code for bite away two?

The FDA product code for bite away two is IRT.

其他以 mibeTec GmbH 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。

K220514bite away neo

相關器械（代碼：IRT）

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。

K220514bite away neomibeTec GmbH K160943咬離Riemser Pharma

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。