Cambridge Heart Micro-V Alternans Sensor, Model 20327-002

• • Terminated Z-1776-2010 FDA Unclassified (pre-2012) ·initiated 29 Apr 2010

  Some kits contained a component with expiration date prior to the date of expiry on the outside of the kit. The user receives feedback of potential unreliable results at several stages during the test process, so any risk of unreliable results is low.

510(k) Number

K002230 ↗

FDA Product Code

DRX

Device Class

Class II

Regulation

21 CFR Part 870.2360

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Heartwave Alternans Processing System, Model Aps

  Class II

  FDA 510(k) K022152 Active Cleared 16 Jul 2002

• Cambridge Heart Ch 2000 Stress Test System

  Class II

  FDA 510(k) K950018 Active Cleared 29 Feb 1996

• Ch 2000 Cardiac Diagnostic System

  Class II

  FDA 510(k) K010756 Active Cleared 12 Apr 2001

• Cardiac Diagnostic System, Model CH2000

  Class II

  FDA 510(k) K022149 Active Cleared 16 Jul 2002

• Cardiac Diagnostic System Model Ch 2000

  Class II

  FDA 510(k) K983102 Active Cleared 12 Apr 1999

• Model Aps Alternans Processing System

  Class II

  FDA 510(k) K001034 Active Cleared 9 Jun 2000

See all devices from Cambridge Heart, Inc. →