FDA.reportPublic FDA data

510(k) K251025

Device
Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
Applicant
Covidien, LLC
510(k) number
K251025
Product code
BZT
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-29
Date received
2025-04-02
Regulation
868.1920
Classification name
Stethoscope, Esophageal, With Electrical Conductors
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Angelica Medina
Address
6135 Gunbarrel Ave. Boulder CO US 80301 80301

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BZT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K193027Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 FrenchDeroyal Industries, Inc.2020-04-02
K140134ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECEStarboard Medical, LLC2014-06-16
K111050ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FRStarboard Medical, LLC2012-04-12
K092716ESOPHAGEAL STETHOSCOPETruer Medical, Inc.2009-09-17
K072621ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSORCincinnati Sub-Zero Products, Inc.2007-12-13
K062020LIFESOUND ESOPHAGEAL STETHOSCOPENovamed, LLC2006-09-05
K982193ESOPHAGEAL STETHOSCOPEShore Medical, Inc.1998-09-01
K973839DISPOSABLE ESOPHAGEAL STETHOSCOPECatheter Research, Inc.1998-03-19
K961060ARISTO ESOPHAGEAL STETHOSCOPEAristo Medical Products, Inc.1996-06-19
K953793INTROSCOPEPolamedco, Inc.1995-11-29
K930929ESOPHAGEAL STETHOSCOPECoast Medical Corp.1995-03-17
K943495DISPOSABLE ESOPHAGEAL STETHOSCOPECoast Medical, Inc.1994-09-08
K940169DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULTI-PURPOSE ESOPHAGEAL STETHOSCOPEDeroyal Industries, Inc.1994-07-28
K925789DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPEDeroyal Industries, Inc.1993-07-13
K930533BNOS MICROVENT(TM), MODEL AC AND MODEL AOBnos Meditech, Ltd.1993-03-29