# K955891: Cardioview Transtelephonic Software

- Pathway: 510(k) (Traditional)
- Applicant: Micromedical, Inc.
- Decided: Oct 8, 1996 after 284 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 K925639 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925639: Cardiomagic Software, Instromedix, Inc. (1993) Summary page 1.

## Most influential descendants
- K981807: Cardiovision Software, Model S-CV5-96 (1998), 0 descendants of its own

## Indications for use
CardioView is a computerized, enhanced electronic Transtelephonic Software System designed for clinical applications to allow physicians or other health care providers to remotely view and analyze patient ECG data. This system is suited for small to medium health care monitoring facilities. If offers a 12 lead ECG remote monitoring system which is more comprehensive than conventional single lead transtelephonic Software.

Source page: https://510kreport.com/device/K955891
Methodology: https://510kreport.com/methodology