Biozdx Hemodynamic Monitor
FDA 510(k) K041294 · Cardiodynamics International Corp.
510(k) numberK041294
Submission
- Device name
- Biozdx Hemodynamic Monitor
- Applicant
- Cardiodynamics International Corp.
San Diego, CA, US - Received
- May 14, 2004
- Decision date
- December 8, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSB – Plethysmograph, Impedance
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2770
- Specialty
- Cardiovascular
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More from Zynex Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K090602 | Cardiodynamics Bioz RX, Model 7101-SYSDSB · Traditional | 05/28/2009SE |
| K070156 | Bioz DX Hemodynamic Monitor with Philips 12-LEAD ECG, Model 5100DSB · Traditional | 09/26/2007SE |
| K051228 | Biozdx Hemodynamic Monitor and 12-LEAD ECGDSB · Traditional | 06/10/2005SE |
| K011439 | Modification to Bioz.Com Hemodynamic MonitorDSB · Traditional | 11/02/2001SE |
| K011797 | Bioztect Sensor and Bioztect CableDSB · Special | 07/03/2001SE |
| K001081 | Bioz.Pc Hemodynamic Monitor Model BZ-500/BZ-501; Bioz.Pc User Software Installation Kit…DSB · Traditional | 06/30/2000SE |
| K001100 | Bioz.Com Hemodynamic Monitor with Bioz Tect Sensor and Bioz Tect Cable Impedance…DSB · Special | 05/05/2000SE |
| K974725 | Bioz.Com SystemDSB · Traditional | 03/18/1998SE |
| K972320 | Bioz System & Bioz PortableDSB · Traditional | 09/11/1997SE |
| K963183 | Bioz SystemDSB · Traditional | 11/26/1996SE |
Questions and answers
When was Biozdx Hemodynamic Monitor cleared by the FDA?
Biozdx Hemodynamic Monitor (K041294) received a 510(k) decision of Substantially Equivalent on December 8, 2004, 208 days after the submission was received.
What is the product code of K041294?
The FDA product code is DSB – Plethysmograph, Impedance, a Class II (moderate risk) device regulated under 21 CFR 870.2770.