Heartwave II Cardiac Diagnostic System

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

510(k) Number

K050225 ↗

FDA Product Code

DQK

Device Class

Class II

Regulation

21 CFR Part 870.1425

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K022152 Active Cleared 16 Jul 2002

• Cambridge Heart Ch 2000 Stress Test System

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  FDA 510(k) K950018 Active Cleared 29 Feb 1996

• Ch 2000 Cardiac Diagnostic System

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  FDA 510(k) K010756 Active Cleared 12 Apr 2001

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  FDA 510(k) K022149 Active Cleared 16 Jul 2002

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

  Class II

  FDA 510(k) K002230 Active Cleared 18 Aug 2000

• Cardiac Diagnostic System Model Ch 2000

  Class II

  FDA 510(k) K983102 Active Cleared 12 Apr 1999

See all devices from Cambridge Heart, Inc. →