C3 and Lifegard Icg Impedance Cardiography Monitors
FDA 510(k) K041434 · Analogic Corp.
510(k) numberK041434
Submission
- Device name
- C3 and Lifegard Icg Impedance Cardiography Monitors
- Applicant
- Analogic Corp.
Peabody, MA, US - Received
- May 28, 2004
- Decision date
- August 6, 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
Other 510(k)s with product code DSB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260224 | MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)DSB · Traditional | ImpediMed Limited | 08/17/2026SE |
| K250634 | BCM2-Body Composition MonitorDSB · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 11/24/2025SE |
| K243727 | Re:BalansDSB · Traditional | Mode Sensors AS | 10/16/2025SE |
| 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 |
|---|---|---|
| K201231 | CTxx85 CT ScannerJAK · Traditional | 02/02/2021SE |
| K182147 | CTXX85JAK · Traditional | 09/07/2018SE |
| K172058 | CT6485, CT12885JAK · Traditional | 02/13/2018SE |
| K161342 | Sonic WindowIYO · Special | 06/15/2016SE |
| K140126 | Sonic WindowIYO · Abbreviated | 03/04/2014SE |
| K071430 | Synerad Omni, Models AN6255 and AN6265KPR · Special | 06/21/2007SE |
| K070829 | Synepix 4600 DetectorMQB · Abbreviated | 05/09/2007SE |
| K051903 | Fetalgard Lite-Nibp, Model Fgl-NibpDXN · Traditional | 12/27/2005SE |
| K052447 | Synerad Impact 60, Synerad Impact 72 and Analogic AMS1600JAK · Abbreviated | 09/21/2005SE |
| K050919 | Lifegard II Family Multi-Function Patient Monitor, Models AN4320, AN4320P, AN4321P…DSI · Abbreviated | 06/14/2005SE |
Questions and answers
When was C3 and Lifegard Icg Impedance Cardiography Monitors cleared by the FDA?
C3 and Lifegard Icg Impedance Cardiography Monitors (K041434) received a 510(k) decision of Substantially Equivalent on August 6, 2004, 70 days after the submission was received.
What is the product code of K041434?
The FDA product code is DSB – Plethysmograph, Impedance, a Class II (moderate risk) device regulated under 21 CFR 870.2770.