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DCG-VII Electrocardioscanner

by Del Mar Avionics 510(k)

Active United States

510(k) K791424

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK791424 Date28 Aug 1979ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DSI
Device Class
Class II
Regulation
21 CFR Part 870.1025
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The DCG-VII Electrocardioscanner is a Detector and Alarm, Arrhythmia device, classified under FDA regulation 870.1025. It is designed to detect and monitor cardiac arrhythmias by analyzing electrocardiographic signals, providing real-time alerts for abnormal heart rhythms. This device falls under the broader category of cardiovascular diagnostic tools, aiding in the early identification of arrhythmic events for clinical assessment.

The DCG-VII Electrocardioscanner is intended for use in clinical settings, such as hospitals or cardiac care units, where continuous monitoring of cardiac activity is required. It is a reusable device, supplied as part of a traditional 510(k) clearance process under FDA classification II. The device’s regulatory status includes a FDA 510(k) clearance (K791424) with a decision of Substantially Equivalent (SESE), granted in 1979. No specific sterility or MRI safety information is provided in the available data.

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