# K963400: Nellcor Symphony N-3000 Patient Monitor with SPO2 and Ecg and N-3200 Display/Printer

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Nov 26, 1996 after 89 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
Longest line of descent: 1 generation back to K902730 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911598: Datascope Passport Monitor, Datascope Corp. (1991) Summary page 2.
- K902730: SPO2 Option, Protocol Systems, Inc. (1990) Summary page 2.
- K905575: Modified Models 2000W and 2000W Option H Apnea Mon, Edentec Corp. (1991) Summary page 2.
- K955642: Nellcor Symphony N-3000 Patient Monitor W/SP02 & Ecg/N-3200 Display/Printer, Nellcor Puritan Bennett, Inc. (1996) Summary page 2.
- K945947: Nellcor Symphony (TM) N-3100 Blood Pressure Monitor and Connected to the Nellcor Symphony (TM) N-3000 Pulse Oximeter, Nellcor, Inc. (1995) Summary page 2.

## Indications for use
The purpose and function of the N-3000 Patient Monitor is to: * noninvasively and continuously monitor functional arterial oxygen saturation and pulse rate (using an accessory SpQO; sensor); * noninvasively and continuously monitor ECG and heart rate (using accessory ECG leads). * noninvasively and continuously measure Respiration Rate. 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 Plethysmograhic waveforms, SpO2, pulse rate, heart rate and respiration rate. When further connected to the N-3100 Blood Pressure Monitor, the intended use of the interconnected N-3000/N-3100/N-3200 is also to: e 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). The N-3000 Patient Monitor is intended for use in hospital and hospital-type 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 during hospital transport when connected to and operating off of the N-3000 and/or N-3200 internal battery, to monitor neonatal, pediatric, or adult patients. The N-3000, N-3200 and N-3100 are for prescription use only.

Source page: https://510kreport.com/device/K963400
Methodology: https://510kreport.com/methodology