Bioz.Com Hemodynamic Monitor with Bioz Tect Sensor and Bioz Tect Cable Impedance Plethysmograph
FDA 510(k) K001100 · Cardiodynamics International Corp.
510(k) numberK001100
Submission
- Device name
- Bioz.Com Hemodynamic Monitor with Bioz Tect Sensor and Bioz Tect Cable Impedance Plethysmograph
- Applicant
- Cardiodynamics International Corp.
San Diego, CA, US - Received
- April 5, 2000
- Decision date
- May 5, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K041294 | Biozdx Hemodynamic MonitorDSB · Traditional | 12/08/2004SE |
| 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 |
| 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 Bioz.Com Hemodynamic Monitor with Bioz Tect Sensor and Bioz Tect Cable Impedance Plethysmograph cleared by the FDA?
Bioz.Com Hemodynamic Monitor with Bioz Tect Sensor and Bioz Tect Cable Impedance Plethysmograph (K001100) received a 510(k) decision of Substantially Equivalent on May 5, 2000, 30 days after the submission was received.
What is the product code of K001100?
The FDA product code is DSB – Plethysmograph, Impedance, a Class II (moderate risk) device regulated under 21 CFR 870.2770.