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FDA 510(k)

LibAirty 氣道清除系統

K 號：K242063 · 2024-12-19

申請人Synchrony Medical , Ltd.
決定日期2024-12-19
產品代碼BYI
諮詢委員會AN
決定相當於

器材摘要

LibAirty Airway Clearance System is the device name listed in this FDA 510(k) record. The listed applicant is Synchrony Medical , Ltd.. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K242063. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LibAirty Airway Clearance System?

LibAirty Airway Clearance System is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Synchrony Medical , Ltd.. The 510(k) number is K242063.

When did LibAirty Airway Clearance System receive FDA 510(k) clearance?

LibAirty Airway Clearance System received FDA 510(k) clearance on 2024-12-19, under 510(k) number K242063.

Who is the listed applicant for LibAirty Airway Clearance System?

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

What is the FDA product code for LibAirty Airway Clearance System?

The FDA product code for LibAirty Airway Clearance System is BYI.

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：BYI）

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。

K252849AffloVest® 移動氣道清除治療Tactile MedicalK250860BreatheBand®（型號 1000）Exemplar Medical, LLCK240959呼吸肌肉訓練器Chongqing Moffy Innovation Technology Co., Ltd.K233441Vest APX 系統（PVAPX1）Baxter Healthcare CorportationK222496Electromed SmartVest 氣道清除系統Electromed, Inc.K201490電流浮動6呼吸道清潔系統Med Systems, Inc.

官方來源

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