FDA 510(k)

呼吸識別 Hp 实验室系統，呼吸識別智慧系統

K 號：K220494 · 2022-06-23

決定日期2022-06-23

產品代碼MSQ

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

BreathID Hp Lab System, BreathID Smart System is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Bioscience Israel , Ltd.. It received FDA 510(k) clearance on 2022-06-23 under 510(k) number K220494. The device is classified under product code MSQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BreathID Hp Lab System, BreathID Smart System?

BreathID Hp Lab System, BreathID Smart System is a medical device that received FDA 510(k) clearance on 2022-06-23. The listed applicant is Meridian Bioscience Israel , Ltd.. The 510(k) number is K220494.

When did BreathID Hp Lab System, BreathID Smart System receive FDA 510(k) clearance?

BreathID Hp Lab System, BreathID Smart System received FDA 510(k) clearance on 2022-06-23, under 510(k) number K220494.

Who is the listed applicant for BreathID Hp Lab System, BreathID Smart System?

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

What is the FDA product code for BreathID Hp Lab System, BreathID Smart System?

The FDA product code for BreathID Hp Lab System, BreathID Smart System is MSQ.

其他以 Meridian Bioscience Israel , 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。

K221896呼吸識別 Hp 系統 K223185呼吸識別® 智能系統

相關器械（代碼：MSQ）

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。

K221896呼吸識別 Hp 系統Meridian Bioscience Israel , Ltd.K223185呼吸識別® 智能系統Meridian Bioscience Israel , Ltd.K193610呼吸識別智慧系統Exalenz Bioscience , Ltd.K173777呼吸識別 Hp 实验室系統Exalenz Bioscience , Ltd.K173772呼吸識別 Hp 系統Exalenz Bioscience , Ltd.K162150呼吸識別 Hp 实验室系統Exalenz Bioscience , Ltd.

官方來源

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