FDA 510(k)

SAM CRRT 計劃，SAM 盒式 CRRT

K 號：K170790 · 2017-12-13

決定日期2017-12-13

產品代碼KDI

諮詢委員會GU

決定相當於

器材摘要

SAM CRRT Unit, SAM Cassette CRRT is the device name listed in this FDA 510(k) record. The listed applicant is Spectral Medical, Inc.. It received FDA 510(k) clearance on 2017-12-13 under 510(k) number K170790. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SAM CRRT Unit, SAM Cassette CRRT?

SAM CRRT Unit, SAM Cassette CRRT is a medical device that received FDA 510(k) clearance on 2017-12-13. The listed applicant is Spectral Medical, Inc.. The 510(k) number is K170790.

When did SAM CRRT Unit, SAM Cassette CRRT receive FDA 510(k) clearance?

SAM CRRT Unit, SAM Cassette CRRT received FDA 510(k) clearance on 2017-12-13, under 510(k) number K170790.

Who is the listed applicant for SAM CRRT Unit, SAM Cassette CRRT?

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

What is the FDA product code for SAM CRRT Unit, SAM Cassette CRRT?

The FDA product code for SAM CRRT Unit, SAM Cassette CRRT is KDI.

其他以 Spectral Medical, Inc. 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。

K183176細菌內毒素活性測試 (EAA)

相關器械（代碼：KDI）

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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官方來源

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