FDA 510(k)

林士龍持續預測呼吸監測系統（CPRMS）

K 號：K240271 · 2024-09-11

決定日期2024-09-11

產品代碼BZQ

諮詢委員會AN

決定相當於

器材摘要

Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) is the device name listed in this FDA 510(k) record. The listed applicant is Linshom Medical, Inc.. It received FDA 510(k) clearance on 2024-09-11 under 510(k) number K240271. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)?

Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) is a medical device that received FDA 510(k) clearance on 2024-09-11. The listed applicant is Linshom Medical, Inc.. The 510(k) number is K240271.

When did Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) receive FDA 510(k) clearance?

Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) received FDA 510(k) clearance on 2024-09-11, under 510(k) number K240271.

Who is the listed applicant for Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)?

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

What is the FDA product code for Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)?

The FDA product code for Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) is BZQ.

其他以 Linshom 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。

K250093林士龍持續預測呼吸監測系統（CPRMS）

相關器械（代碼：BZQ）

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。

K253274BedDot (G1)Intelligent Dots, LLC K251326呼吸速率算法Edwards Lifesciences, LLC K250093林士龍持續預測呼吸監測系統（CPRMS）Linshom Medical, Inc.K250934Respiree 心肺監護系統Respiree Pte, Ltd.K243183RTMsense 呼吸監測系統Rtm Vital Signs, LLC K243966臉心生命指標軟體開發工具包（FH生命指標SDK-RR）Faceheart Corp.

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