FDA 510(k)

每物

K 號：K242485 · 2025-05-20

決定日期2025-05-20

產品代碼MOD

諮詢委員會AN

決定相當於

器材摘要

EveryWare is the device name listed in this FDA 510(k) record. The listed applicant is Breas Medical AB. It received FDA 510(k) clearance on 2025-05-20 under 510(k) number K242485. The device is classified under product code MOD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EveryWare?

EveryWare is a medical device that received FDA 510(k) clearance on 2025-05-20. The listed applicant is Breas Medical AB. The 510(k) number is K242485.

When did EveryWare receive FDA 510(k) clearance?

EveryWare received FDA 510(k) clearance on 2025-05-20, under 510(k) number K242485.

Who is the listed applicant for EveryWare?

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

What is the FDA product code for EveryWare?

The FDA product code for EveryWare is MOD.

其他以 Breas Medical AB 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。

K242438清朗 K233452Vivo 45 LS K240778Vivo 1, Vivo 2 K240779Vivo 3 K193586Vivo 45 LS K160481Vivo 60

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相關器械（代碼：MOD）

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。

K261360EasyCare Tx 2Resmed Corp K253807Valence InVent Xtend™ (CVG-4101-VXA)Convergence Medical Sciences , Ltd.K260051CorVision® (91-205-Z0014)CorVent® Medical, Inc.K161411照護週期連接應用程序Respironics, Inc.

官方來源

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