Ascentia Heartstation ECG Management System

• • Terminated Z-0366-2010 FDA Unclassified (pre-2012) ·initiated 7 May 2009 ·on shared 510(k) K050858

  HeartStation does not refresh content changes to the PDF reports that are printed emailed or faxed from the Index page. This may lead to a discrepancy in patient demographics between what is displayed in the HeartStation Client interface and the report delivered to the consumer. Questions are being directed to the local Agfa representative; the contact information was included in the letter.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K050858 ↗

FDA Product Code

DPS

Device Class

Class II

Regulation

21 CFR Part 870.2340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Echonet

  Class II

  FDA 510(k) K954860 Active Cleared 21 Dec 1995

• Ultrasound Capture System

  Class II

  FDA 510(k) K042042 Active Cleared 21 Sep 2004

• Dicomview

  Class I

  FDA 510(k) K954479 Active Cleared 21 Feb 1996

• Modification to Encompass

  Class II

  FDA 510(k) K040896 Active Cleared 16 Jul 2004

• Heartlab Cardiovascular

  Class II

  FDA 510(k) K050228 Active Cleared 18 Feb 2005