Aristo Esophageal Stethoscope
FDA 510(k) K961060 · Aristo Medical Products, Inc.
510(k) numberK961060
Submission
- Device name
- Aristo Esophageal Stethoscope
- Applicant
- Aristo Medical Products, Inc.
Waukesha, WI, US - Received
- March 18, 1996
- Decision date
- June 19, 1996
- 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 |
| K973839 | Disposable Esophageal StethoscopeBZT · Traditional | Catheter Research, Inc. | 03/19/1998SE |
| K953793 | IntroscopeBZT · Traditional | Polamedco, Inc. | 11/29/1995SE |
More from Polamedco, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K960251 | Comsat Adult,Pediatric,Infant,Neonatal Disposable Sensor and Comsat Reusable Finger SensorDQA · Traditional | 03/26/1996SE |
| K953817 | Aristo Medical Model 2101 Patient MonitorDQA · Traditional | 11/22/1995SE |
| K920966 | Sdi Oxygen/Digital Oxygen Transducers (Dot)DQA · Traditional | 07/16/1993SE |
Questions and answers
When was Aristo Esophageal Stethoscope cleared by the FDA?
Aristo Esophageal Stethoscope (K961060) received a 510(k) decision of Substantially Equivalent on June 19, 1996, 93 days after the submission was received.
What is the product code of K961060?
The FDA product code is BZT – Stethoscope, Esophageal, With Electrical Conductors, a Class II (moderate risk) device regulated under 21 CFR 868.1920.