Paceart Pacemaker Patient Test Syst/Tel Opt Cpts

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K880283 ↗

FDA Product Code

DXH

Device Class

Class II

Regulation

21 CFR Part 870.2920

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Pacemaker Function Analyzer

  Class II

  FDA 510(k) K870909 Active Cleared 27 Apr 1987

• Paceart Cardiovoice

  Class II

  FDA 510(k) K952065 Active Cleared 16 Jan 1996

• Paceart TX3 Cardiac Event Recorder

  Class II

  FDA 510(k) K012407 Active Cleared 14 Aug 2001

• Paceart Cardiophone

  Class II

  FDA 510(k) K931296 Active Cleared 1 Oct 1993

• Home Trak Plus EASI Event Recorder System

  Class II

  FDA 510(k) K982090 Active Cleared 26 Jan 1999

• Heart Access Plus Cardiac Event Recorder

  Class II

  FDA 510(k) K973141 Active Cleared 12 Nov 1997

See all devices from Paceart, Inc. →

• What is the PACEART Pacemaker Patient Test System used for?

  This device is a transmitter and receiver for electrocardiograph telephone use, intended for patient testing and communication purposes in a medical setting.

• Is the PACEART Pacemaker Patient Test System reusable?

  No, the device is supplied as a single-use system and is not reusable.

• What is the regulatory status of the PACEART Pacemaker Patient Test System?

  The device is regulated under FDA 510(k) clearance and has a registration number of 3013689228.

• Is the PACEART Pacemaker Patient Test System MRI safe?

  No, the device is not specified as MRI safe.