Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2310](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2310) → DQH — Cardiograph, Apex (Vibrocardiograph)

# DQH · Cardiograph, Apex (Vibrocardiograph)

_Cardiovascular · 21 CFR 870.2310 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQH

## Overview

- **Product Code:** DQH
- **Device Name:** Cardiograph, Apex (Vibrocardiograph)
- **Regulation:** [21 CFR 870.2310](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2310)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## Identification

An apex cardiograph (vibrocardiograph) is a device used to amplify or condition the signal from an apex cardiographic transducer and to produce a visual display of the motion of the heart; this device also provides any excitation energy required by the transducer.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K974697](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQH/K974697.md) | REUSABLE FINGER SENSOR 3444 | Bci Intl., Inc. | Mar 11, 1998 | SESE |

## Top Applicants

- Bci Intl., Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQH](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQH)

**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
