510(k) K251025
K251025 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)". The FDA issued a decision of Substantially Equivalent on December 29, 2025. The device falls under product code BZT (Stethoscope, Esophageal, With Electrical Conductors), a Class II device regulated under 21 CFR 868.1920. Covidien, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 2025
- Date Received
- April 2, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stethoscope, Esophageal, With Electrical Conductors
- Device Class
- Class II
- Regulation Number
- 868.1920
- Review Panel
- AN
- Submission Type