Bioimpedance Cardiac Analyzing Measuring System, Model Nicas 2004 Slim
FDA 510(k) K070500 · Ni Medical
510(k) numberK070500
Submission
- Device name
- Bioimpedance Cardiac Analyzing Measuring System, Model Nicas 2004 Slim
- Applicant
- Ni Medical
Warrington, PA, US - Received
- February 21, 2007
- Decision date
- July 16, 2007
- 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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| K260224 | MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)DSB · Traditional | ImpediMed Limited | 08/17/2026SE |
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| K250922 | Edema Guard Monitor (EGM) CardioSet-001DSB · Traditional | Cardioset Medical , Ltd. | 09/09/2025SE |
| K232089 | SOZO ProDSB · Traditional | ImpediMed Limited | 10/17/2023SE |
| K223217 | Zynex Monitoring System, Model CM-1600DSB · Traditional | Zynex Medical, Inc. | 06/16/2023SE |
| K211585 | Bodyport Cardiac ScaleDSB · Traditional | Bodyport, Inc. | 07/29/2022SE |
| K203473 | SozoDSB · Traditional | ImpediMed Limited | 04/19/2021SE |
| K193410 | SOZO Body Fluid AnalyzerDSB · Traditional | ImpediMed Limited | 10/02/2020SE |
| K191697 | Cardiac Monitor 1500DSB · Traditional | Zynex Medical, Inc. | 02/21/2020SE |
More from Zynex Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K972001 | Nicas(Tm) ElectrodeDRX · Traditional | 07/08/1997SE |
Questions and answers
When was Bioimpedance Cardiac Analyzing Measuring System, Model Nicas 2004 Slim cleared by the FDA?
Bioimpedance Cardiac Analyzing Measuring System, Model Nicas 2004 Slim (K070500) received a 510(k) decision of Substantially Equivalent on July 16, 2007, 145 days after the submission was received.
What is the product code of K070500?
The FDA product code is DSB – Plethysmograph, Impedance, a Class II (moderate risk) device regulated under 21 CFR 870.2770.