← Product Code [DSI](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI) · K850136

# CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM (K850136)

_Cardio Data · DSI · Feb 1, 1985 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K850136

## Device Facts

- **Applicant:** Cardio Data
- **Product Code:** [DSI](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI.md)
- **Decision Date:** Feb 1, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1025
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

## Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K850136](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K850136)

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