# K083820: Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-C

- Pathway: 510(k) (Traditional)
- Applicant: Vasomedical, Inc.
- Decided: Apr 1, 2009 after 100 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: 3 generations back to K943862 (1995). 7 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070818: MEDILOGAR4, MEDILOGAR12, Tom Medical Entwicklungs GmbH (2007) Summary page 1.
- K053369: Medilog Darwin Holter Analysis, Huntleigh Healthcare (2005) Summary page 1.

## Most influential descendants
- K101022: Pulmotrack 5050 Wholter, Model 5050 (2010), 6 descendants of its own
- K110525: Vitalograph Model 7100 - Vitalojak (2011), 5 descendants of its own
- K201077: Strados Remote Electronic Stethoscope Platform (RESP) (2020), 3 descendants of its own
- K092785: Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis Software, 2301 (2010), 3 descendants of its own
- K220893: Strados Remote Electronic Stethoscope Platform (RESP) (2022), 2 descendants of its own

## Indications for use
The Ambulatory ECG Recorder described in this 510(k) Premarket Notification is a non-invasive device intended to acquire, record and store ambulatory three (3) channel ECG signals from the upper body surface of adults and children over the age of six years old for a minimum of 24 hours. It works in concert with the CB Series Analysis Software to playback, review, analyze, edit and print ECG data. The software does not perform diagnostics. These data are used by physicians for diagnostic evaluations.

Source page: https://510kreport.com/device/K083820
Methodology: https://510kreport.com/methodology