Pediarity™
K 號：K231531 · 2023-12-21
廣告
器材摘要
Pediarity™ is the device name listed in this FDA 510(k) record. The listed applicant is Hinlab, Inc.. It received FDA 510(k) clearance on 2023-12-21 under 510(k) number K231531. 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 Pediarity™?
Pediarity™ is a medical device that received FDA 510(k) clearance on 2023-12-21. The listed applicant is Hinlab, Inc.. The 510(k) number is K231531.
When did Pediarity™ receive FDA 510(k) clearance?
Pediarity™ received FDA 510(k) clearance on 2023-12-21, under 510(k) number K231531.
Who is the listed applicant for Pediarity™?
The FDA 510(k) record lists Hinlab, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pediarity™?
The FDA product code for Pediarity™ 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