Pathfinder 700 Holter Analyzer

• • Terminated Z-2611-2011 FDA Unclassified (pre-2012) ·initiated 24 May 2011

  A potential hazard associated with the use of Spacelabs Healthcare Pathfinder Holter Analyzer software. The second 24 hours of a 48 hours EVO recording will not be analyzed.

510(k) Number

K951902 ↗

FDA Product Code

DQK

FDA applicant

Reynolds Medical , Ltd.

Device Class

Class II

Regulation

21 CFR Part 870.1425

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. →