FDA 510(k)

XactTrace單次使用呼吸努力帶系統

K 號：K173793 · 2019-03-01

決定日期2019-03-01

產品代碼MNR

諮詢委員會AN

決定相當於

器材摘要

XactTrace Single Use Respiratory Effort Belt System is the device name listed in this FDA 510(k) record. The listed applicant is Embla Systems. It received FDA 510(k) clearance on 2019-03-01 under 510(k) number K173793. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the XactTrace Single Use Respiratory Effort Belt System?

XactTrace Single Use Respiratory Effort Belt System is a medical device that received FDA 510(k) clearance on 2019-03-01. The listed applicant is Embla Systems. The 510(k) number is K173793.

When did XactTrace Single Use Respiratory Effort Belt System receive FDA 510(k) clearance?

XactTrace Single Use Respiratory Effort Belt System received FDA 510(k) clearance on 2019-03-01, under 510(k) number K173793.

Who is the listed applicant for XactTrace Single Use Respiratory Effort Belt System?

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

What is the FDA product code for XactTrace Single Use Respiratory Effort Belt System?

The FDA product code for XactTrace Single Use Respiratory Effort Belt System is MNR.

其他以 Embla Systems 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。

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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。

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