K251025
- 510(k) number
- K251025
- Device name
- Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
- Applicant
- Covidien, LLC CO · US
- Product code
- BZT — Stethoscope, Esophageal, With Electrical Conductors
- Decision date
- 2025-12-29
- Date received
- 2025-04-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251025.pdf
Official FDA record: K251025
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.