Spacelabs Alpha Pc Patient Computer

• • Terminated Z-2382-2012 FDA Class II ·initiated 27 Aug 2012

  There is a potential failure of the Integrated Module Housing causing the patient module parameters to drop off the monitor display or the patient module will fail to sign on when inserted into the housing.

• • Terminated Z-0063-06 FDA Unclassified (pre-2012) ·initiated 16 Sep 2005

  ECG 5-lead cable miswired - A physician could interpret the incorrect polarities as a conduction defect.

510(k) Number

K842616 ↗

FDA Product Code

DSI

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Heartrate Plus ECG Cardule #1918

  Class II

  FDA 510(k) K830306 Active Cleared 17 Mar 1983

• Spacelabs Series 1000

  Class II

  FDA 510(k) K760612 Active Cleared 21 Sep 1976

• Spacelabs Series 90700 Patient Monitors

  Class II

  FDA 510(k) K862951 Active Cleared 23 Sep 1986

• Spacelabs-General System Link

  Class II

  FDA 510(k) K850627 Active Cleared 28 May 1985

• Spacelabs Arrhythmia Net (Tm) Level 2

  Class II

  FDA 510(k) K864505 Active Cleared 24 Nov 1986

• Space Labs Model 90560

  Not classified

  FDA 510(k) K923788 Active Cleared 6 Dec 1993

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