Ceegraph/Sleepscan Netlink Traveler

• • Terminated Z-0001-2008 FDA Unclassified (pre-2012) ·initiated 26 Jul 2007 ·on shared 510(k) K052066

  Bio-logic System Corp Camera Pole may weaken and detach at the base of the telescoping camera pole during transport causing pole to break at the welded base and fall.

• • Terminated Z-0761-2007 FDA Unclassified (pre-2012) ·initiated 26 Feb 2007 ·on shared 510(k) K052066

  Battery and Battery Compartment; incorrect placement in the Netlink Traveler unit which caused a short in the wiring of the battery pack and overheating.

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

510(k) Number

K052066 ↗

FDA Product Code

OLV

Device Class

Class II

Regulation

21 CFR Part 882.1400

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Sleepscan

  Class II

  FDA 510(k) K894155 Active Cleared 26 Jan 1990

• Disposable Cutaneous Electrodes

  Class II

  FDA 510(k) K941799 Active Cleared 3 Feb 1995

• Bio-Logic Master Evoked Response System

  Class II

  FDA 510(k) K021895 Active Cleared 1 Jul 2002

• Ceegraph Traveler Ambulatory EEG Recorder

  Class II

  FDA 510(k) K954954 Active Cleared 25 Jan 1996

• SLEEPSCAN Airflow Pressure Transducer

  Class II

  FDA 510(k) K971501 Active Cleared 14 Oct 1997

• Bio-Logic Sleepscan Product With Built-In Oximeter

  Class II

  FDA 510(k) K962103 Active Cleared 22 Aug 1996

See all devices from Bio-Logic Systems Corp. →