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Holter Ssr Digicorder

by Del Mar Avionics 510(k)

Active United States

510(k) K942653

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK942653 Date10 May 1995ClearedStatusActive

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  • Withdrawn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)

Full name
Holter Ssr Digicorder(Tm)
510(k) Number
FDA Product Code
DSH
Device Class
Class II
Regulation
21 CFR Part 870.2800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

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

The Holter Ssr Digicorder is a medical device classified as a Recorder, Magnetic Tape, Medical, designed for continuous ambulatory electrocardiographic (ECG) monitoring. It records heart rhythm data over extended periods, typically 24 to 48 hours, to diagnose arrhythmias, ischemia, or other cardiac abnormalities. The device captures electrical activity from the heart and stores it on magnetic tape for later analysis by healthcare professionals.

This device is supplied as a reusable medical recorder and is intended for use in clinical settings such as hospitals, cardiology clinics, or outpatient facilities. It operates under FDA 510(k) clearance (K942653) and falls under regulation 870.2800, classified as a Class II device. The Holter Ssr Digicorder is not specified as single-use or sterile, and its magnetic tape storage requires proper handling and archival per manufacturer guidelines. No MRI safety information is provided in the available data.

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