Holter PacerCorder

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

Full name

Holter Pacercorder(R)

510(k) Number

K950020 ↗

FDA Product Code

DSH

Device Class

Class II

Regulation

21 CFR Part 870.2800

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cardioguard Stress Test Monitor 4002

  Class II

  FDA 510(k) K850043 Active Cleared 8 Feb 1985

• Model 9300 Electrocardiovalidator

  Class I

  FDA 510(k) K801830 Active Cleared 27 Aug 1980

• Model 463 Electrocardiorecorder Recorder

  Class II

  FDA 510(k) K884330 Active Cleared 5 Jan 1989

• Holter Digicorder with Pacer Option (Model 483)

  Class II

  FDA 510(k) K963174 Active Cleared 13 Mar 1997

• Treadmill E-17

  Class I

  FDA 510(k) K850044 Active Cleared 4 Apr 1985

• Ote Biomedical #1296 - 16 Chan. Record

  Class II

  FDA 510(k) K820779 Active Cleared 26 Apr 1982

See all devices from Del Mar Avionics →

• What is the Holter PacerCorder used for?

  The Holter PacerCorder is a medical device used for cardiovascular monitoring. It records cardiac activity over extended periods to aid in the diagnosis and management of heart conditions.

• How is the Holter PacerCorder supplied?

  The device is supplied as a Class II medical device with FDA 510(k) clearance K950020. It is manufactured by Del Mar Avionics and intended for use in cardiovascular settings.

• What is the regulatory status of the Holter PacerCorder?

  The Holter PacerCorder has FDA 510(k) clearance K950020, granted on August 17, 1995. It is regulated under product code DSH and regulation number 870.2800.

• Is the Holter PacerCorder a single-use or reusable device?

  The device data does not specify whether the Holter PacerCorder is single-use or reusable. This information would need to be obtained directly from the manufacturer or product documentation.