Stethoscope with Temperature Sensor
FDA 510(k) K791190 · National Catheter Co. Div. Mallinckrodt
510(k) numberK791190
Submission
- Device name
- Stethoscope with Temperature Sensor
- Applicant
- National Catheter Co. Div. Mallinckrodt
Mchenry, IL, US - Received
- June 26, 1979
- Decision date
- July 6, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K973839 | Disposable Esophageal StethoscopeBZT · Traditional | Catheter Research, Inc. | 03/19/1998SE |
| K961060 | Aristo Esophageal StethoscopeBZT · Traditional | Aristo Medical Products, Inc. | 06/19/1996SE |
More from Aristo Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K802918 | Anthron Catheter SetFOZ · Traditional | 04/21/1981SE |
| K802505 | Double Lumen Tracheal TubeBTR · Traditional | 03/13/1981SE |
| K810321 | Reinforced Tracheostomy Tube Set(Tentat)BTO · Traditional | 03/04/1981SE |
| K801924 | Hi-Lo Temp Gen. Purpose Temp. ProbeFLL · Traditional | 09/09/1980SE |
| K801005 | MLT Tube Microlaryngeal Tracheal Tube)BTR · Traditional | 05/23/1980SE |
| K781665 | Tube, Leatherman/ImbruceGBA · Traditional | 12/15/1978SE |
| K770727 | Manipulator & Injector, UterineKNA · Traditional | 04/26/1977SE |
Questions and answers
When was Stethoscope with Temperature Sensor cleared by the FDA?
Stethoscope with Temperature Sensor (K791190) received a 510(k) decision of Substantially Equivalent on July 6, 1979, 10 days after the submission was received.
What is the product code of K791190?
The FDA product code is BZT – Stethoscope, Esophageal, With Electrical Conductors, a Class II (moderate risk) device regulated under 21 CFR 868.1920.