Icon, Model C3
FDA 510(k) K082242 · Osypka Medical, Inc.
510(k) numberK082242
Submission
- Device name
- Icon, Model C3
- Applicant
- Osypka Medical, Inc.
La Jolla, CA, US - Received
- August 7, 2008
- Decision date
- October 8, 2008
- 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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| 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 |
|---|---|---|
| K123916 | Psa SeriesDTE · Traditional | 04/09/2013SESK |
| K081035 | Aesculon C2, Aesculon CHF Clinic C2, Aesculon Hypertension Clinic C2 and Aesculon…DSB · Special | 05/30/2008SE |
| K070985 | Aesculon CHF, Hypertension & Pacemaker ClinicDSB · Traditional | 02/01/2008SE |
| K033130 | Pace 101/PACE 101H, Model 3077 Ssi Temporary Pulse GeneratorDTE · Special | 10/31/2003SE |
| K022939 | Oscor Pace 101/101H and Accessories, St.Jude Medical Model 3077 and…DTE · Special | 10/03/2002SE |
| K020896 | Oscor Pace 203/PACE 203H Dual-Chamber Temporary Pacemaker, St. Jude Medical, Model 3085…DTE · Abbreviated | 06/14/2002SE |
Questions and answers
When was Icon, Model C3 cleared by the FDA?
Icon, Model C3 (K082242) received a 510(k) decision of Substantially Equivalent on October 8, 2008, 62 days after the submission was received.
What is the product code of K082242?
The FDA product code is DSB – Plethysmograph, Impedance, a Class II (moderate risk) device regulated under 21 CFR 870.2770.