FDA 510(k)

Mon-a-Therm™ 食管式聽診器配溫度感測器 400TM (90041, 90042, 90043, 90049)

K 號：K251025 · 2025-12-29

決定日期2025-12-29

產品代碼BZT

諮詢委員會AN

決定相當於

器材摘要

Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2025-12-29 under 510(k) number K251025. The device is classified under product code BZT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)?

Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) is a medical device that received FDA 510(k) clearance on 2025-12-29. The listed applicant is Covidien, LLC. The 510(k) number is K251025.

When did Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) receive FDA 510(k) clearance?

Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) received FDA 510(k) clearance on 2025-12-29, under 510(k) number K251025.

Who is the listed applicant for Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)?

FDA 510(k) 記錄將 Covidien, LLC 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)?

The FDA product code for Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) is BZT.

其他以 Covidien, LLC 為申請人之記錄

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相關器械（代碼：BZT）

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。

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官方來源

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