# K173036: North-vision Multi-parameter Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: North-Vision Tech., Inc.
- Decided: Dec 21, 2018 after 449 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: 12 generations back to K941811 (1994). 118 ancestors in all.
No later device cites it as a predicate yet.
1 of 119 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123711: Patient Monitor, Shenzhen Creative Industry Co., Ltd. (2013) Summary page 4.

## Indications for use
The North-vision Elegant-1000 Series of Multi-parameter Patient Monitor are intended to monitor, display and record physiological signs of adult, pediatric patients. With the functions of near real-time recording and displaying parameters ECG, heart rate, non-invasive blood pressure, functional oxygen saturation, it allows comprehensive analysis of patient’s physiological conditions. This apparatus is applicable for use in hospitals, clinics, and practitioner’s office. The operation should be carried out by qualified professionals only.

Source page: https://510kreport.com/device/K173036
Methodology: https://510kreport.com/methodology