# K173461: ECG recorder and Arrhythmia Detector

- Pathway: 510(k) (Traditional)
- Applicant: Smart Solutions Technologies SL
- Decided: Aug 3, 2018 after 269 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K963725 (1997). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143513: ZIO SR ECG Monitoring Service, iRhythm Technologies, Inc. (2015) Summary page 4.

## Most influential descendants
- K231620: Nuubo Smart (2023), 0 descendants of its own

## Indications for use
The Nuubo System is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, presyncope, syncope, fatigue, or anxiety. The Nuubo system continuously records and stores ECG and activity data for up to 30 days at a time. The Nuubo System detects arrhythmias at the end of the monitoring period upon download of the ECG data. The Nuubo System is Rx use device

Source page: https://510kreport.com/device/K173461
Methodology: https://510kreport.com/methodology