Critikon #817 Esophageal Multi-Probe
FDA 510(k) K821890 · Critikon Company, LLC
510(k) numberK821890
Submission
- Device name
- Critikon #817 Esophageal Multi-Probe
- Applicant
- Critikon Company, LLC
Mchenry, IL, US - Received
- June 25, 1982
- Decision date
- August 3, 1982
- 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
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| 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 |
|---|---|---|
| K002248 | Dinamap Pro 1000 Monitor, Model 1000DXN · Traditional | 09/21/2000SE |
| K000500 | Dinamap Advanced Nibp ModuleDXN · Traditional | 05/26/2000SE |
| K992638 | Dinamap Pro Series Monitor, Models 100, 200, 300, 400MWI · Traditional | 02/24/2000SE |
| K982342 | Dinamap MPS Select Portable MonitorMSX · Traditional | 08/14/1998SE |
| K943709 | Dinamap Plus Vital Signs MonoitorDPS · Traditional | 06/16/1995SE |
| K942700 | Dinamap Vital Signs Monitor Models 9300 and 9320/9340MHX · Traditional | 03/01/1995SE |
| K933404 | Critikon Central Statin MonitorDPS · Traditional | 02/09/1994SE |
| K933050 | Changes to Protectiv(Tm) & Jelco(Tm) Winged CathFOZ · Traditional | 12/14/1993SE |
| K915697 | Critikon Vital Signs ModuleDXN · Traditional | 07/01/1993SE |
| K921295 | Intravenous Catheters ModificationsFGO · Traditional | 05/17/1993SE |
Questions and answers
When was Critikon #817 Esophageal Multi-Probe cleared by the FDA?
Critikon #817 Esophageal Multi-Probe (K821890) received a 510(k) decision of Substantially Equivalent on August 3, 1982, 39 days after the submission was received.
What is the product code of K821890?
The FDA product code is BZT – Stethoscope, Esophageal, With Electrical Conductors, a Class II (moderate risk) device regulated under 21 CFR 868.1920.