迴路系統
K 號：K181352 · 2019-03-29
廣告
器材摘要
Loop System is the device name listed in this FDA 510(k) record. The listed applicant is Spry Health, Inc.. It received FDA 510(k) clearance on 2019-03-29 under 510(k) number K181352. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Loop System?
Loop System is a medical device that received FDA 510(k) clearance on 2019-03-29. The listed applicant is Spry Health, Inc.. The 510(k) number is K181352.
When did Loop System receive FDA 510(k) clearance?
Loop System received FDA 510(k) clearance on 2019-03-29, under 510(k) number K181352.
Who is the listed applicant for Loop System?
The FDA 510(k) record lists Spry Health, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Loop System?
The FDA product code for Loop System is DQA.
相關臨床試驗
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。
相關器械（代碼：DQA）
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。
K252821可重用成人SpO2夾式感測器（3m）（M1196A）；可重用成人SpO2夾式感測器（0.9m）（M1196T）Philips Medizin Systeme Böblingen GmbHK252655心脈血氧濃度計（PO-A2AO、PO-A2AT、PO-A3AO、PO-H1AO、PO-B1AO、PO-C5AO、PO-C5AT、PO-C6AO、PO-C6AT）Shenzhen Imdk Medical Technology Co., Ltd.K253887鼻翼SpO2感測器（989803205381）；鼻翼SpO2感測器（989803205391）；鼻翼Sp02感測器（989803205401）Philips Medizin SystemeK260931Unimed可重用手指夾式SpO2感測器（U403-49R及U103-49R）Unimed Medical Supplies, Inc.K252448AViTA脉搏血氧儀 (SP61)Avita CorporationK252805YUWELL®手指血氧計（YX105、YX106、YX110、YX310）Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
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。
廣告