ZYMED TELEMETRY SYSTEM - Model T8010

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

510(k) Number

K951370 ↗

FDA Product Code

DSI

Models / Variants

Zymed Telemetry System

Model T8010

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Zymed Telemetry System, Model Easi View

  Class II

  FDA 510(k) K984089 Active Cleared 16 Feb 1999

• Modification to Zymed Holter 2000

  Class II

  FDA 510(k) K992197 Active Cleared 28 Jul 1999

• Holter 2000

  Class II

  FDA 510(k) K990170 Active Cleared 13 Apr 1999

• Zymed Holter Scanner Model 2010

  Class II

  FDA 510(k) K955015 Active Cleared 18 Mar 1996

• Zybit

  Class II

  FDA 510(k) K002004 Active Cleared 21 Sep 2000

• Multitrak-Plus

  Class II

  FDA 510(k) K930894 Active Cleared 1 Nov 1993