Thermodilution Cardiac Output Computer, Mod. COM-2
FDA 510(k) K872529 · American Edwards Laboratories
510(k) numberK872529
Submission
- Device name
- Thermodilution Cardiac Output Computer, Mod. COM-2
- Applicant
- American Edwards Laboratories
Santa Ana, CA, US - Received
- June 26, 1987
- Decision date
- September 15, 1987
- 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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More from Lidco, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K873485 | Edslab (R) Occlusion Balloon CatheterDQY · Traditional | 12/03/1987SE |
| K872596 | Trantec Disposable Pressure TRANS.53-600/F/F30DRS · Traditional | 09/30/1987SE |
| K870444 | Homepro II Volumetric Infusion PumpFRN · Traditional | 04/17/1987SE |
| K864997 | Medtrac VP Volumetric Infusion PumpFRN · Traditional | 02/27/1987SE |
| K864330 | Shear Force GaugeDXE · Traditional | 01/06/1987SE |
| K862724 | Vein Valve CutterDQY · Traditional | 01/02/1987SE |
| K864155 | Modification of Carpentier-Edwards BioprosthesisDTJ · Traditional | 11/20/1986SE |
| K863596 | Chin-Fogarty Inflation DeviceDXT · Traditional | 11/20/1986SE |
| K863986 | Xenon Light Source for Endoscopic ProceduresHRX · Traditional | 10/31/1986SE |
| K862872 | Flexible Visualization CatheterFEI · Traditional | 10/24/1986SE |
Questions and answers
When was Thermodilution Cardiac Output Computer, Mod. COM-2 cleared by the FDA?
Thermodilution Cardiac Output Computer, Mod. COM-2 (K872529) received a 510(k) decision of Substantially Equivalent on September 15, 1987, 81 days after the submission was received.
What is the product code of K872529?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.