FDA 510(k)

病人監護儀，型號 LM-8、LM-10、LM-12 及 LM-15

K 號：K221879 · 2022-08-10

決定日期2022-08-10

產品代碼MHX

諮詢委員會履歷

決定相當於

器材摘要

Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 is the device name listed in this FDA 510(k) record. The listed applicant is Caf Medical Solutions, Inc.. It received FDA 510(k) clearance on 2022-08-10 under 510(k) number K221879. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Patient Monitor, models LM-8, LM-10, LM-12 and LM-15?

Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 is a medical device that received FDA 510(k) clearance on 2022-08-10. The listed applicant is Caf Medical Solutions, Inc.. The 510(k) number is K221879.

When did Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 receive FDA 510(k) clearance?

Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 received FDA 510(k) clearance on 2022-08-10, under 510(k) number K221879.

Who is the listed applicant for Patient Monitor, models LM-8, LM-10, LM-12 and LM-15?

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

What is the FDA product code for Patient Monitor, models LM-8, LM-10, LM-12 and LM-15?

The FDA product code for Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 is MHX.

其他以 Caf Medical Solutions, 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。

K221616病人監護儀，型號 LMPLUS-12、LMPLUS-15 及 LMPLUS-17 K220362LE-12CH

相關器械（代碼：MHX）

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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