# K955642: Nellcor Symphony N-3000 Patient Monitor W/SP02 & Ecg/N-3200 Display/Printer

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Jul 2, 1996 after 203 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
817 later devices descend from it; 3 cite it directly.
6 of 818 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).
- (no number) Datascope PASSPORT: named in the summary without a submission number
- (no number) Protocol Systems PROPAQ 104: named in the summary without a submission number
- (no number) NELLCOR SYMPHONY™ N-3000 Pulse Oximeter: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K345847: NELLCOR SYMPHONY™ N-3100 Blood Pressure Monitor. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K991823: N-395 Pulse Oximeter, Model N-395 (1999), 785 descendants of its own
- K993637: N-395 Pulse Oximeter, with Extended Device Claims (1999), 715 descendants of its own
- K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories) (2002), 548 descendants of its own
- K021090: Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter (2002), 426 descendants of its own
- K031740: VSM - Vital Signs Monitor, Model 53000 Series (2003), 290 descendants of its own

## Indications for use
The purpose and function of the N-3000E Patient Monitor is to: * noninvasively and continuously monitor functional arterial oxygen saturation and pulse rate (using an accessory SpO₂ sensor), * noninvasively and continuously monitor ECG and heart rate (using accessory ECG leads). When connected to the N-3200 Display/Printer, the purpose and function of the combined device is expanded to: display and print out associated ECG and plethysmographic waveforms, SpO₂, pulse rate and heart rate. When further connected to the N-3100 Blood Pressure Monitor, the intended use of the interconnected N-3000E/N-3100/N-3200 is also to: noninvasively and automatically measure systolic, diastolic and mean arterial blood pressure and to derive pulse rate from these measurements (using accessory blood pressure cuffs); and display and print out systolic, diastolic and mean arterial blood pressure (on the N-3200 display/printer). When the N-3100 is connected to the N-3200 Display/Printer, the purpose and function of the combined device (compared to K345847) is expanded to: display and print out associated pulse rate and systolic, diastolic and mean arterial blood pressure. The N-3000E Patient Monitor is intended for use in hospital, hospital-type and hospital transport environments as a “standalone” product and when connected to the N-3200 display/printer and/or the N-3100 blood pressure monitor. It is also intended for use to monitor neonatal, pediatric, or adult patients. The N-3000E, N-3200 and N-3100 are for prescription use only.

Source page: https://510kreport.com/device/K955642
Methodology: https://510kreport.com/methodology