免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

Tyto Insights for Wheeze Detection (with PCCP)

K 號：K252844 · 2026-06-02

申請人Tyto Care , Ltd.
決定日期2026-06-02
產品代碼PHZ
諮詢委員會AN
決定Substantially Equivalent

器材摘要

Tyto Insights for Wheeze Detection (with PCCP) 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 2026-06-02 under 510(k) number K252844. The device is classified under product code PHZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tyto Insights for Wheeze Detection (with PCCP)?

Tyto Insights for Wheeze Detection (with PCCP) is a medical device that received FDA 510(k) clearance on 2026-06-02. The listed applicant is Tyto Care , Ltd.. The 510(k) number is K252844.

When did Tyto Insights for Wheeze Detection (with PCCP) receive FDA 510(k) clearance?

Tyto Insights for Wheeze Detection (with PCCP) received FDA 510(k) clearance on 2026-06-02, under 510(k) number K252844.

Who is the listed applicant for Tyto Insights for Wheeze Detection (with PCCP)?

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 Insights for Wheeze Detection (with PCCP)?

The FDA product code for Tyto Insights for Wheeze Detection (with PCCP) is PHZ.

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 Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751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

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。

K252089Tyto Stethoscope (G3)K243567Tyto Insights for Rhonchi DetectionK240555Tyto Insights for Crackles DetectionK232237Tyto Insights for Wheeze DetectionK221614TytoCare Lung Sounds AnalyzerK190242Tyto Thermometer

查看所有 9 項裝置 →

相關器械（代碼：PHZ）

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。

K260140Aevice Wheeze Detection ModuleAevice Health Pte. , Ltd.K243567Tyto Insights for Rhonchi DetectionTyto Care , Ltd.K240555Tyto Insights for Crackles DetectionTyto Care , Ltd.K232237Tyto Insights for Wheeze DetectionTyto Care , Ltd.K221614TytoCare Lung Sounds AnalyzerTyto Care , Ltd.K202062wheezo WheezeRate DetectorRespiri Limited

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。

↑