MX1002 Cable-Cal TM
FDA 510(k) K880696 · Medex, Inc.
510(k) numberK880696
Submission
- Device name
- MX1002 Cable-Cal TM
- Applicant
- Medex, Inc.
Hilliard, OH, US - Received
- February 22, 1988
- Decision date
- June 15, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1435
- Specialty
- Cardiovascular
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| K181372 | ArgosDXG · Traditional | Retia Medical, LLC | 12/13/2018SE |
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| K163334 | LiDCOunity v2 Hemodynamic MonitorDXG · Traditional | Lidco, Ltd. | 06/05/2017SE |
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| K042432 | Pharmguard Toolbox, Model G6000782FRN · Traditional | 01/04/2005SE |
| K040899 | Medex 3000 Series MR Syringe Infusion PumpFRN · Traditional | 04/30/2004SE |
| K020780 | Transtar Intracranial Pressure Transducer, Model MX950ICPGWM · Abbreviated | 05/20/2002SE |
| K000328 | Medex 3000 Series MRI Compatible Syringe Infusion PumpFRN · Traditional | 05/09/2000SE |
| K982640 | Medex 3000 Series Syringe Infusion PumpFRN · Traditional | 04/06/1999ST |
| K982123 | Contrast Control DeviceFPA · Traditional | 07/21/1998SE |
| K955231 | Medfusion Model 2001 Syringe Infusion PumpFRN · Traditional | 07/18/1996ST |
| K961404 | MX960 Reusable Pressure TransducerDRS · Traditional | 06/27/1996SE |
Questions and answers
When was MX1002 Cable-Cal TM cleared by the FDA?
MX1002 Cable-Cal TM (K880696) received a 510(k) decision of Substantially Equivalent on June 15, 1988, 114 days after the submission was received.
What is the product code of K880696?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.