Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with Temperature Sensor
FDA 510(k) K072621 · Cincinnati Sub-Zero Products, Inc.
510(k) numberK072621
Submission
- Device name
- Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with Temperature Sensor
- Applicant
- Cincinnati Sub-Zero Products, Inc.
Sharonville, OH, US - Received
- September 17, 2007
- Decision date
- December 13, 2007
- 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 |
| 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 |
| 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 |
|---|---|---|
| K123946 | Warmair Model 135 Hyperthermia System Including Filteredflo BlanketsDWJ · Special | 01/17/2013SE |
| K122813 | Hemotherm Model 400CE Cooler/Heater SystemDWC · Traditional | 12/18/2012SE |
| K121669 | Warmair Model 135 Hyperthermia System (Controller and Blankets)DWJ · Special | 07/03/2012SE |
| K120081 | Norm-O-Temp Hyperthermia System Incliding Blankets/PadsDWJ · Traditional | 02/17/2012SE |
| K110104 | Blanketrol II Hyper-Hypothermia Temperature Managment SystemDWJ · Traditional | 02/04/2011SE |
| K101148 | Warm Air Model 135 Hyperthermia System and BlanketsDWJ · Traditional | 10/01/2010SE |
| K101589 | Blanketrol III, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia SystemsDWJ · Traditional | 09/20/2010SE |
| K070339 | Disposable Temperature Probes/Sensors and Instrument CablesFLL · Traditional | 09/26/2007SE |
| K942790 | Warm Air Hypertheermia System (Models #130 and #133)DWJ · Traditional | 01/24/1995SE |
| K942599 | Warm Air Warming UnitDWJ · Traditional | 01/24/1995SE |
Questions and answers
When was Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with Temperature Sensor cleared by the FDA?
Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with Temperature Sensor (K072621) received a 510(k) decision of Substantially Equivalent on December 13, 2007, 87 days after the submission was received.
What is the product code of K072621?
The FDA product code is BZT – Stethoscope, Esophageal, With Electrical Conductors, a Class II (moderate risk) device regulated under 21 CFR 868.1920.