# K013311: Modification to: Pocketview Ecg Software

- Pathway: 510(k) (Special)
- Applicant: Micromedical Industries, Ltd.
- Decided: Jan 3, 2002 after 91 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cardioview™ 3000 software: named in the summary without a submission number

## Indications for use
PocketView ECG software is a version of Cardioview™ 3000 software, a Windows-based program intended to interpret electrocardiograms, for use on a personal digital assistant (PDA). PocketView ECG software receives, displays and stores a single or standard 12 Lead Simultaneous ECG recording which is transmitted either locally or transtelephonically using a proprietary digital data transmission protocol. The device contains proprietary software algorithms to receive, store, analyze, and interpret the ECG signal.

Source page: https://510kreport.com/device/K013311
Methodology: https://510kreport.com/methodology