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Intermedics Triangle Chest Probe Model 526-04

by Intermedics, Inc. 510(k)

Active United States

510(k) K933278

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK933278 Date15 Mar 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  • Withdrawn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)

510(k) Number
FDA Product Code
KRG
Device Class
Class III
Regulation
21 CFR Part 870.3700
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Intermedics Triangle Chest Probe Model 526-04 is a chest electrode probe designed for use in cardiac monitoring and pacing systems. It is intended for transcutaneous electrical stimulation and signal acquisition during electrocardiographic procedures, facilitating accurate detection of cardiac activity and pacing signal delivery.

This device is supplied as a reusable medical instrument and is classified under FDA regulation number 870.3700 as a Class III device. It is intended for use in clinical settings where cardiac monitoring is required, such as hospitals and cardiac care units. The probe adheres to FDA 510(k) clearance (K933278) and is regulated under the KRG product code, ensuring compliance with cardiovascular device standards.

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