Apex Oximeter

• • Terminated Z-0631-2010 FDA Unclassified (pre-2012) ·initiated 25 Sep 2009

  Potential misuse of the ApexPro Telemetry System and incorrect message and alarm information in the ApexPro Operator's Manual may impact patient safety. When ApexPro Telemetry systems are used with SpO2 oximeters: 1. ApexPro FH Transceiver can operate with the ApexPro FH Xpod connected, but without ECG lead wires attached to the transceiver. This is unintended use of the device that is not do

510(k) Number

K980299 ↗

FDA Product Code

DQA

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Quantitative Sentinel System

  Class II

  FDA 510(k) K993008 Active Cleared 6 Dec 1999

• Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (Aci-Tipi) Option

  Not classified

  FDA 510(k) K974199 Active Cleared 6 Feb 1998

• Dash 1000 Patient Monitor

  Class II

  FDA 510(k) K970545 Active Cleared 8 May 1997

• Cardiosmart St

  Not classified

  FDA 510(k) K973403 Active Cleared 12 Mar 1998

• Muse Cardiovascular Information System

  Not classified

  FDA 510(k) K980495 Active Cleared 7 May 1998

• Rac 2A Module Housing

  Class II

  FDA 510(k) K973984 Active Cleared 16 Jan 1998

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