# K040357: M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry Monitoring System II

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems, Inc.
- Decided: Mar 3, 2004 after 19 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K941811 (1994). 63 ancestors in all.
260 later devices descend from it; 27 cite it directly.
0 of 324 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031403: M3290A Intellivue Information Center Software Release E.1, Philips Medical Systems, Inc. (2003) Summary page 1.
- K021251: ST/AR ST and Arrhythmia Software, Release E.I., Philips Medical Systems (2002) Summary page 1.
- K993516: HP M2600A Viridia Telemetry System, Hewlett-Packard Co. (1999) Summary page 1.
- K021300: Modification of Philips Component Compact Monitor, Release a.03, Model M1275B, Philips Medical Systems (2002) Summary page 1.
- K030038: Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185 Opt C41 Wireless Bedside Adaptr, Philips Medical Systems, Inc. (2003) Summary page 1.

## Most influential descendants
- K041235: Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors (2004), 252 descendants of its own
- K042845: The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors (2004), 251 descendants of its own
- K050141: The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient Monitors (2005), 250 descendants of its own
- K050762: Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90 (2005), 249 descendants of its own
- K051106: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors (2005), 247 descendants of its own

## Indications for use
M3290A: For central monitoring of multiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms. M4840A: For ambulatory and bedside monitoring of ECG and SpO2 parameters of adult and pediatric patients in healthcare facilities to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

Source page: https://510kreport.com/device/K040357
Methodology: https://510kreport.com/methodology