Disposable Esophageal Stethoscope
FDA 510(k) K973839 · Catheter Research, Inc.
510(k) numberK973839
Submission
- Device name
- Disposable Esophageal Stethoscope
- Applicant
- Catheter Research, Inc.
Indianapolis, IN, US - Received
- October 8, 1997
- Decision date
- March 19, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BZT – Stethoscope, Esophageal, With Electrical Conductors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1920
- Specialty
- Anesthesiology
Other 510(k)s with product code BZT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251025 | Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043…BZT · Traditional | Covidien, LLC | 12/29/2025SE |
| K193027 | Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal…BZT · Traditional | Deroyal Industries, Inc. | 04/02/2020SE |
| K140134 | Esophageal Stethoscope with Temperature Sensor (Non-Sterile),Esophageal Stethoscope…BZT · Traditional | Starboard Medical, LLC | 06/16/2014SE |
| K111050 | Esophageal / Rectal Temperature Probe, 9FR, 12FR, Esophageal Stethoscope with…BZT · Traditional | Starboard Medical, LLC | 04/12/2012SE |
| K092716 | Esophageal StethoscopeBZT · Traditional | Truer Medical, Inc. | 09/17/2009SE |
| K072621 | Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with Temperature SensorBZT · Traditional | Cincinnati Sub-Zero Products, Inc. | 12/13/2007SE |
| K062020 | Lifesound Esophageal StethoscopeBZT · Traditional | Novamed, LLC | 09/05/2006SE |
| K982193 | Esophageal StethoscopeBZT · Traditional | Shore Medical, Inc. | 09/01/1998SE |
| K961060 | Aristo Esophageal StethoscopeBZT · Traditional | Aristo Medical Products, Inc. | 06/19/1996SE |
| K953793 | IntroscopeBZT · Traditional | Polamedco, Inc. | 11/29/1995SE |
More from Polamedco, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K123258 | The Advance Catheter for HSG and SisLKF · Special | 01/31/2013SE |
| K120154 | Intrauterine Insemination (Iui) CatheterMQF · Abbreviated | 03/21/2012SE |
| K032835 | H/S Catheter SetLKF · Traditional | 12/11/2003SE |
| K020292 | Uterine InjectorLKF · Traditional | 04/17/2002SE |
| K974357 | Uterine Manipulator/InjectorLKF · Traditional | 02/02/1998SE |
| K951345 | Disposable Airway Connectors for Gas SamplingBZA · Traditional | 04/14/1995SE |
| K946044 | Disposable Gas Sampling LinesCCK · Traditional | 12/27/1994SE |
Questions and answers
When was Disposable Esophageal Stethoscope cleared by the FDA?
Disposable Esophageal Stethoscope (K973839) received a 510(k) decision of Substantially Equivalent on March 19, 1998, 162 days after the submission was received.
What is the product code of K973839?
The FDA product code is BZT – Stethoscope, Esophageal, With Electrical Conductors, a Class II (moderate risk) device regulated under 21 CFR 868.1920.