Nicom
FDA 510(k) K042144 · Cheetah Medical, Inc.
510(k) numberK042144
Submission
- Device name
- Nicom
- Applicant
- Cheetah Medical, Inc.
M.P. Misgav, IL - Received
- August 9, 2004
- Decision date
- November 12, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1435
- Specialty
- Cardiovascular
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|---|---|---|---|
| K253092 | Argos Infinity (Rev. 1.0)DXG · Traditional | Retia Medical Systems, Inc. | 02/13/2026SE |
| K251275 | VitalStream ART Connect; VitalStream-HemoDXG · Traditional | Caretaker Medical | 09/26/2025SE |
| K232048 | Cogent Hemodynamic Monitoring System; Cogent HMSDXG · Traditional | Icu Medical | 12/20/2023SE |
| K212529 | Hypotension Decision Assist Model HDA-OR2DXG · Special | Directed Systems, Ltd. | 11/23/2021SE |
| K192169 | PulsioFlex Monitoring System with ProAQT SensorDXG · Traditional | Pulsion Medical Systems SE | 04/30/2020SE |
| K193179 | EV1000 Clinical PlatformDXG · Special | Edwards Lifesciences, LLC | 12/17/2019SE |
| K190955 | Hypotension Decision AssistDXG · Traditional | Directed Systems, Ltd. | 11/27/2019SE |
| K181372 | ArgosDXG · Traditional | Retia Medical, LLC | 12/13/2018SE |
| K172259 | PulsioFlex Monitoring SystemDXG · Traditional | Pulsion Medical Systems SE | 01/18/2018SE |
| K163334 | LiDCOunity v2 Hemodynamic MonitorDXG · Traditional | Lidco, Ltd. | 06/05/2017SE |
More from Lidco, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K103166 | Cheetah ReliantDSB · Abbreviated | 01/25/2011SE |
| K101487 | Cheetah Nicom SystemDXG · Abbreviated | 07/02/2010SE |
| K083093 | Cheetah ReliantDSB · Abbreviated | 12/15/2008SE |
| K071631 | Nicom ElectrodesDXG · Traditional | 01/18/2008SE |
| K072662 | Cheetah Reliant, Cheetah ActiveDSB · Traditional | 01/16/2008SE |
| K023370 | Cheetah I.V.D.S., Model 2002PDQK · Traditional | 12/24/2002SE |
Questions and answers
When was Nicom cleared by the FDA?
Nicom (K042144) received a 510(k) decision of Substantially Equivalent on November 12, 2004, 95 days after the submission was received.
What is the product code of K042144?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.