Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1025](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1025) → QYW — Hospital Cardiac Telemetry

# QYW · Hospital Cardiac Telemetry

_Cardiovascular · 21 CFR 870.1025 · Class 2_

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

## Overview

- **Product Code:** QYW
- **Device Name:** Hospital Cardiac Telemetry
- **Regulation:** [21 CFR 870.1025](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1025)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **Life-sustaining:** yes

## 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.

## Classification Rationale

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.

## 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.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K133973](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QYW/K133973.md) | TEMPUS PRO WITH ENHANCED FEATURES | Remote Diagnostic Technologies , Ltd. | Aug 14, 2014 | SESE |
| [K934913](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QYW/K934913.md) | HEARTRAC ECG MONITORING SYSTEM | Cardiac Telecom Corp. | Jun 5, 1995 | SESE |

## Top Applicants

- Cardiac Telecom Corp. — 1 clearance
- Remote Diagnostic Technologies , Ltd. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com