FDA 510(k)

泰托聽診器（G3）

K 號：K252089 · 2026-03-12

決定日期2026-03-12

產品代碼DQD

諮詢委員會履歷

決定相當於

器材摘要

Tyto Stethoscope (G3) is the device name listed in this FDA 510(k) record. The listed applicant is Tyto Care , Ltd.. It received FDA 510(k) clearance on 2026-03-12 under 510(k) number K252089. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tyto Stethoscope (G3)?

Tyto Stethoscope (G3) is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Tyto Care , Ltd.. The 510(k) number is K252089.

When did Tyto Stethoscope (G3) receive FDA 510(k) clearance?

Tyto Stethoscope (G3) received FDA 510(k) clearance on 2026-03-12, under 510(k) number K252089.

Who is the listed applicant for Tyto Stethoscope (G3)?

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

What is the FDA product code for Tyto Stethoscope (G3)?

The FDA product code for Tyto Stethoscope (G3) is DQD.

其他以 Tyto Care , Ltd. 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。

K252844Tyto Insights 開放性喘息偵測設備（含PCCP）K243567Tyto Insights 開放性喘鳴偵測系統 K240555Tyto Insights 開裂聲檢測系統 K232237泰途呼吸異常偵測洞察系統 K221614泰途醫療肺音分析器 K190242泰托醫用儀器體溫計

查看所有 9 項裝置 →

相關器械（代碼：DQD）

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。

K261494智慧無線聽診器（STEMO310）；智慧無線聽診器（STEMO710）；智慧無線聽診器（STEMO720）；智慧無線聽診器（STEMO730）Shanghai Hulu Devices Co., Ltd.K261694核心300數位聽診器Eko Health, Inc.K252915AiSteth®Ai Health Highway India Pvt., Ltd.K252076膝聲軟骨評估系統（750-3600-001）Kneevoice, Inc.K252284eMurmur Heart AICsd Labs K252595聽診器ProSparrow Acoustics, Inc.

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。