# K973735: Microvit MT-100

- Pathway: 510(k) (Traditional)
- Applicant: Schiller America, Inc.
- Decided: Aug 25, 1998 after 329 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
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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K745130: Braemar DL 700 Holter Monitor. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The ECG Holter device, MICROVIT MT-100, is a recording device used to record long term Electrocardiographs for the diagnostics of symptomatic and asymptomatic arrhythmias, i.e. bradycardia, tachycardia, dfagnostic of arrhythmias in patients with coronary artery disease, in patients after reanimation, in patients with different diseases such as cardio- myopathy, high blood pressure, long QT syndrome. A Holter ECG recording is also used for clarifying palpitations or syncopes and attacks of dizziness or for controlling medical therapies, or after operative treatments such as bypass operations or PTCA. The ST segment analysis of a Holter ECG is .used for the detection of symptomatic or asymptomatic {schemias.

Source page: https://510kreport.com/device/K973735
Methodology: https://510kreport.com/methodology