E-RAM

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

510(k) Number

K884126 ↗

FDA Product Code

DSH

FDA applicant

Reynolds Medical , Ltd.

Device Class

Class II

Regulation

21 CFR Part 870.2800

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Sentinel

  Class II

  FDA 510(k) K062397 Active Cleared 25 Jan 2007

• Hrv Tools

  Class II

  FDA 510(k) K040313 Active Cleared 6 Apr 2004

• Cardionavigator +

  Class II

  FDA 510(k) K051960 Active Cleared 19 Aug 2005

• Lifecard Cf Compact Recorder

  Class II

  FDA 510(k) K001025 Active Cleared 19 Apr 2000

• Cardionavigator Information Management System

  Class II

  FDA 510(k) K011345 Active Cleared 20 Jul 2001

• Cardiocall Cardiac Event Recorder

  Class II

  FDA 510(k) K972649 Active Cleared 4 Dec 1997

See all devices from Reynolds Medical, Ltd. →

• What is the E-RAM device used for?

  The E-RAM is a medical device designed for cardiovascular applications. It records medical data using magnetic tape technology, specifically intended for use in cardiovascular settings.

• Is the E-RAM a single-use device or can it be reused?

  The E-RAM is supplied as a single-use device, meaning it is designed for one-time use only and should not be reused for patient safety and regulatory compliance reasons.

• What are the storage requirements for the E-RAM device?

  The E-RAM device should be stored at room temperature. This storage condition helps maintain the integrity of the magnetic tape and ensures proper functionality when the device is used.

• Is the E-RAM MRI compatible?

  No, the E-RAM is not MRI compatible. The device uses magnetic tape technology which may be affected by the strong magnetic fields present in MRI environments, potentially compromising data recording accuracy.