Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
FDA 510(k) K193027 · Deroyal Industries, Inc.
510(k) numberK193027
Submission
- Device name
- Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
- Applicant
- Deroyal Industries, Inc.
Powell, TN, US - Received
- October 30, 2019
- Decision date
- April 2, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| K973839 | Disposable Esophageal StethoscopeBZT · Traditional | Catheter Research, Inc. | 03/19/1998SE |
| 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 |
|---|---|---|
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam…OMP · Traditional | 11/21/2025SE |
| K230233 | Prospera Spectruum Negative Pressure Wound Therapy SystemOMP · Traditional | 04/18/2024SE |
| K200631 | DeRoyal Temperature Monitoring ProbeFLL · Traditional | 12/23/2020SE |
| K200757 | Foley Catheter with Temperature SensorEYC · Traditional | 10/15/2020SE |
| K200319 | HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface…FMT · Traditional | 04/02/2020SE |
| K191425 | Hydro-Temp Neonatal Skin Temperature Probe CoverFMT · Traditional | 01/21/2020SE |
| K173072 | Algidex Ag Silver Alginate Wound DressingFRO · Traditional | 04/04/2018SE |
| K171475 | DeRoyal Laprador Specimen Retrieval SystemGCJ · Traditional | 08/17/2017SE |
| K152978 | DeRoyal Angiography KitsDXT · Traditional | 03/25/2016SESK |
| K142962 | PROTOCOL Incision DressingFRO · Traditional | 07/23/2015SE |
Questions and answers
When was Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French cleared by the FDA?
Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French (K193027) received a 510(k) decision of Substantially Equivalent on April 2, 2020, 155 days after the submission was received.
What is the product code of K193027?
The FDA product code is BZT – Stethoscope, Esophageal, With Electrical Conductors, a Class II (moderate risk) device regulated under 21 CFR 868.1920.