FDA 510(k)

呼吸速率算法

K 號：K251326 · 2026-06-11

決定日期2026-06-11

產品代碼BZQ

諮詢委員會AN

決定相當於

器材摘要

Respiration Rate algorithm is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K251326. 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 Respiration Rate algorithm?

Respiration Rate algorithm is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K251326.

When did Respiration Rate algorithm receive FDA 510(k) clearance?

Respiration Rate algorithm received FDA 510(k) clearance on 2026-06-11, under 510(k) number K251326.

Who is the listed applicant for Respiration Rate algorithm?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Respiration Rate algorithm?

The FDA product code for Respiration Rate algorithm is BZQ.

其他以 Edwards Lifesciences, LLC 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。

K253186HemoSphere Nano 監控器 (HSNANO1)K251982愛德華斯MC3 三尖瓣環成形環（4900）K251688卡彭蒂埃-愛德華斯物理環成形環 (4450)K242518高血壓預測指數（HePI）演算法 K242909FloTrac感測器；FloTrac Jr感測器；Acumen IQ感測器；VolumeView感測器 K240078福吉瑞透亮血栓切除导管

查看所有 53 項裝置 →

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 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.K242001飛利浦 VSC-MEDlibPhilips Medical Systems Nederland B.V.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。