Oximetrix Accu Sat CPB
FDA 510(k) K811391 · Oximetrix, Inc.
510(k) numberK811391
Submission
- Device name
- Oximetrix Accu Sat CPB
- Applicant
- Oximetrix, Inc.
Mchenry, IL, US - Received
- May 18, 1981
- Decision date
- July 20, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRY – Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4330
- Specialty
- Cardiovascular
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| K202557 | Quantum Workstation 12 EliteDRY · Special | Spectrum Medical , Ltd. | 10/02/2020SE |
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| K163657 | Quantum WorkstationDRY · Special | Spectrum Medical , Ltd. | 01/18/2017SE |
| K133157 | Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda Bioactive Surface…DRY · Traditional | Medtronic, Inc. | 10/23/2014SE |
| K133658 | Cdi Blood Parameter Monitoring System 500DRY · Traditional | Terumo Cardiovascular Systems Corp. | 07/25/2014SE |
| K123039 | Cdi Blood Parameter Monitoring System 500DRY · Traditional | Terumo Cardiovascular Systems Corp. | 11/20/2012SE |
More from Terumo Cardiovascular Systems Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K853018 | Model 3000 Opticath ComputerDXG · Traditional | 01/13/1986SE |
| K842622 | Hemo Static/Esu Scalpel SystemGEI · Traditional | 10/23/1984SE |
| K833966 | Pump Infusion Wearable Infusion PumpJSJ · Traditional | 01/25/1984SE |
| K823007 | Opticath Heparin Coated, Flow-DirectDYG · Traditional | 11/01/1982SE |
| K821057 | Flow Directed Thermal-Dilution InfusionDYG · Traditional | 05/18/1982SE |
| K821056 | Flow Directed Thermal-Dilution Catheter · Traditional | 05/18/1982SE |
| K820674 | OpticathDQE · Traditional | 03/25/1982SE |
| K791868 | Oximetrix Shaw Hemostatic Surg. Sys.GEI · Traditional | 01/04/1980SE |
| K781879 | Heater, Oximeter SystemDQA · Traditional | 01/08/1979SE |
| K781134 | Catheter, Thermal Dilution FiberopticDQE · Traditional | 08/17/1978SE |
Questions and answers
When was Oximetrix Accu Sat CPB cleared by the FDA?
Oximetrix Accu Sat CPB (K811391) received a 510(k) decision of Substantially Equivalent on July 20, 1981, 63 days after the submission was received.
What is the product code of K811391?
The FDA product code is DRY – Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4330.