Icg Module
FDA 510(k) K010164 · General Electric Medical Systems Information Techn
510(k) numberK010164
Submission
- Device name
- Icg Module
- Applicant
- General Electric Medical Systems Information Techn
Milwaukee, WI, US - Received
- January 18, 2001
- Decision date
- April 9, 2001
- 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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| 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 |
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| K021454 | Unity Network IdMWI · Traditional | 10/01/2002SE |
| K020290 | Dash 3000/4000 Patient MonitorMHX · Traditional | 08/14/2002SE |
| K021366 | Mac-Lab/Cardiolab Ep/CombolabDQK · Special | 07/03/2002SE |
| K020661 | Unity Is Patient ViewerMSX · Traditional | 05/24/2002SE |
| K021325 | Modification of Apexpro Telemetry SystemMHX · Special | 05/07/2002SE |
| K020524 | Patientnet Monitoring SystemMSX · Special | 03/20/2002SE |
| K012467 | Solar 8000M SystemDSI · Traditional | 02/11/2002SE |
Questions and answers
When was Icg Module cleared by the FDA?
Icg Module (K010164) received a 510(k) decision of Substantially Equivalent on April 9, 2001, 81 days after the submission was received.
What is the product code of K010164?
The FDA product code is DSB – Plethysmograph, Impedance, a Class II (moderate risk) device regulated under 21 CFR 870.2770.