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Model 152 Delta Holter Ecg Analysis System

by Del Mar Avionics 510(k)

Active United States

510(k) K891148

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK891148 Date11 May 1989ClearedStatusActive

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  • Withdrawn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, 22 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 Model 152 Delta Holter Ecg Analysis System is a Detector And Alarm, Arrhythmia device, classified under the medical specialty of Cardiovascular. It is designed to analyze electrocardiogram (ECG) data. The device is used for Holter monitoring, which involves the continuous recording of a patient's ECG over an extended period.

The Model 152 Delta Holter Ecg Analysis System is supplied by Del Mar Avionics and has been authorized with FDA 510K clearance, specifically with the clearance number K891148. The device is classified under the product code DSI and regulation number 870.1025. It is intended for use in a clinical setting, with the specific details of its use and storage not provided in the available data.

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Questions

AI-generated answers, 22 Sep 2026

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

  • What is the Model 152 Delta Holter ECG Analysis System used for?

    The Model 152 Delta Holter ECG Analysis System is used for Holter monitoring, which involves the continuous recording of a patient's electrocardiogram (ECG) over an extended period.

  • What type of device is the Model 152 Delta?

    The Model 152 Delta is a Detector And Alarm, Arrhythmia device, classified under the medical specialty of Cardiovascular.

  • Is the Model 152 Delta Holter ECG Analysis System supplied sterile?

    The available data does not provide information on the sterility of the Model 152 Delta Holter ECG Analysis System.

  • What is the regulatory classification of the Model 152 Delta?

    The Model 152 Delta is classified under the product code DSI and regulation number 870.1025, and has been authorized with FDA 510K clearance.