BZT · Stethoscope, Esophageal, With Electrical Conductors
Anesthesiology · 21 CFR 868.1920 · Class 2
Overview
| Product Code | BZT |
|---|---|
| Device Name | Stethoscope, Esophageal, With Electrical Conductors |
| Regulation | 21 CFR 868.1920 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
An esophageal stethoscope with electrical conductors is a device that is inserted into the esophagus to listen to a patient's heart and breath sounds and to monitor electrophysiological signals. The device may also incorporate a thermistor for temperature measurement.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 46)
Showing 20 most recent of 46 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251025 | Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) | Covidien, LLC | Dec 29, 2025 | SESE |
| K193027 | Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French | Deroyal Industries, Inc. | Apr 2, 2020 | SESE |
| K140134 | ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE | Starboard Medical, LLC | Jun 16, 2014 | SESE |
| K111050 | ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR | Starboard Medical, LLC | Apr 12, 2012 | SESE |
| K092716 | ESOPHAGEAL STETHOSCOPE | Truer Medical, Inc. | Sep 17, 2009 | SESE |
| K072621 | ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR | Cincinnati Sub-Zero Products, Inc. | Dec 13, 2007 | SESE |
| K062020 | LIFESOUND ESOPHAGEAL STETHOSCOPE | Novamed, LLC | Sep 5, 2006 | SESE |
| K982193 | ESOPHAGEAL STETHOSCOPE | Shore Medical, Inc. | Sep 1, 1998 | SESE |
| K973839 | DISPOSABLE ESOPHAGEAL STETHOSCOPE | Catheter Research, Inc. | Mar 19, 1998 | SESE |
| K961060 | ARISTO ESOPHAGEAL STETHOSCOPE | Aristo Medical Products, Inc. | Jun 19, 1996 | SESE |
| K953793 | INTROSCOPE | Polamedco, Inc. | Nov 29, 1995 | SESE |
| K930929 | ESOPHAGEAL STETHOSCOPE | Coast Medical Corp. | Mar 17, 1995 | SESE |
| K943495 | DISPOSABLE ESOPHAGEAL STETHOSCOPE | Coast Medical, Inc. | Sep 8, 1994 | SESE |
| K940169 | DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULTI-PURPOSE ESOPHAGEAL STETHOSCOPE | Deroyal Industries, Inc. | Jul 28, 1994 | SESE |
| K925789 | DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPE | Deroyal Industries, Inc. | Jul 13, 1993 | SESE |
| K930533 | BNOS MICROVENT(TM), MODEL AC AND MODEL AO | Bnos Meditech, Ltd. | Mar 29, 1993 | SESE |
| K922007 | YSI MODEL 441A AIRWAY TEMPERATURE PROBE | Yellow Springs Instrument Co., Inc. | Nov 4, 1992 | SESE |
| K904943 | TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE | Arzco Medical Electronics, Inc. | Apr 26, 1991 | SESE |
| K894757 | T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE | Louisville Laboratories, Inc. | Sep 18, 1989 | SESE |
| K893409 | YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP | Yellow Springs Instrument Co., Inc. | Jul 20, 1989 | SESE |
Top Applicants
- Sheridan Catheter Corp. — 4 clearances
- Deroyal Industries, Inc. — 3 clearances
- Biomedical Concepts, Inc. — 2 clearances
- Portex, Inc. — 2 clearances
- Respiratory Support Products, Inc. — 2 clearances
