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Paceline Patient Transmitter Model 324

by Pacesetter Systems 510(k)

Active United States

510(k) K831443

Overview

The Paceline Patient Transmitter Model 324 is a transmitter and receiver device used for electrocardiograph telephone transmission. It is designed to transmit patient cardiac data for monitoring purposes.

This device is supplied by Pacesetter Systems and is classified as a Class II medical device. It received FDA 510(k) clearance with the K number K831443 on August 12, 1983, and is intended for cardiovascular applications.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK831443 Date12 Aug 1983ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
DXH
Device Class
Class II
Regulation
21 CFR Part 870.2920
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Paceline Patient Transmitter Model 324 used for?

    The Paceline Patient Transmitter Model 324 is designed to transmit patient cardiac data for monitoring purposes. It functions as both a transmitter and receiver device specifically for electrocardiograph telephone transmission, allowing healthcare providers to remotely monitor cardiovascular data.

  • How is the Paceline Patient Transmitter Model 324 supplied?

    The device is supplied by Pacesetter Systems. It is classified as a Class II medical device and is intended for cardiovascular applications. The manufacturer provides this device for use in transmitting electrocardiograph data via telephone systems.

  • What is the regulatory status of the Paceline Patient Transmitter Model 324?

    The Paceline Patient Transmitter Model 324 received FDA 510(k) clearance with K number K831443 on August 12, 1983. It is classified as a Class II medical device and is considered substantially equivalent to other devices in its product code category DXH for cardiovascular applications.

  • Is the Paceline Patient Transmitter Model 324 reusable or single-use?

    The device data does not specify whether the Paceline Patient Transmitter Model 324 is designed for single-use or multiple uses. As a Class II medical device with electrocardiograph transmission capabilities, its intended use pattern would depend on the specific clinical application and manufacturer guidelines.