Solar 8000M System

• • Ongoing Z-0523-2019 FDA Class II ·initiated 31 Aug 2018 ·on shared 510(k) K012467

  The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

• • Terminated Z-0285-2009 FDA Unclassified (pre-2012) ·initiated 2 Apr 2008

  A software error has been discovered when using Combination Monitoring with Solar 8000M/i - PDM - Telemetry in combo mode. This error has only been noted with this particular configuration and mode of monitoring. It has not been observed in other monitoring applications. The software error will result in a reset of the Solar 8000M/i, causing a loss of monitoring for approximately 1-2 minutes a

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

510(k) Number

K012467 ↗

FDA Product Code

DSI

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Case 8000 Exercise Testing System

  Not classified

  FDA 510(k) K991014 Active Cleared 20 Oct 1999

• Solar 7/8000

  Class II

  FDA 510(k) K993757 Active Cleared 23 Mar 2000

• Bis/EEG Module

  Class II

  FDA 510(k) K012466 Active Cleared 1 Oct 2001

• Dash 3000 Patient Monitor Open recall

  Class II

  FDA 510(k) K992929 Active Cleared 26 Nov 1999

• Dash 3000/4000 Patient Monitor Open recall

  Class II

  FDA 510(k) K001359 Active Cleared 18 Jul 2000

• Corometrics Model 171 and 172 Fetal Monitor

  Class II

  FDA 510(k) K991905 Active Cleared 1 Sep 1999

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