Natus 515-013100

• FDA 510(k) K991054 decided 3 Nov 1999 Active
• FDA GUDID UDI-DI 00382830037624 listed 16 Sep 2016 Listed

• • Terminated Z-1256-2010 FDA Unclassified (pre-2012) ·initiated 8 Mar 2010 ·on shared 510(k) K991054

  CareFusion NeuroCare is voluntarily implementing a field correction to delete certain NicoletOne software protocols, which users may interpret incorrectly when conducting patient evaluations. This may result in the misinterpretation of the left versus right side of the brain. Users are being provided with instructions for removing these protocols and verifying that the deletion has been prop

• • Terminated Z-2459-2008 FDA Unclassified (pre-2012) ·initiated 13 Jun 2008 ·on shared 510(k) K991054

  NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. Cardinal Health NeuroCare has confirmed that the 3rd party room relay connected to the A2 wall plate does not always activate if the patient event button connected to the CSeries Amplifier is pressed twice within one second.

• • Terminated Z-2389-2008 FDA Unclassified (pre-2012) ·initiated 5 Jun 2008 ·on shared 510(k) K991054

  Cardinal Health NeuroCare is implementing a voluntary field correction to replace a quantity of photic adapter cables, part number 085-463700, used to connect the NicLED Photic Strobe option, part number 698-625500, with NicoletOne EEG system. The photic adapter cable has a wiring error which delivers a reduced voltage and results in a decreased intensity of the NicLED photic. This reduced intensi

• • Terminated Z-0380-2007 FDA Unclassified (pre-2012) ·initiated 25 Aug 2006 ·on shared 510(k) K991054

  A software anomaly exists in the 5.20.1038 NicoletOne LTM, Sleep, nEEG, vEEG and ICU Monitor systems using the M, and/or C series amplifiers. If this anomaly occurs, the system will display the data for channel one in all channels on NicoletOne LTM, Sleep, nEEG, vEEG or ICU Monitor systems.

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

1. 3 Nov 1999 Cleared FDA 510(k) K991054
2. 25 Aug 2006 Recall initiated FDA recalls Z-0380-2007
3. 5 Jun 2008 Recall initiated FDA recalls Z-2389-2008
4. 13 Jun 2008 Recall initiated FDA recalls Z-2459-2008
5. 8 Mar 2010 Recall initiated FDA recalls Z-1256-2010
6. 16 Sep 2016 Listed FDA GUDID 00382830037624

Trade name

Natus

Generic name

Electromyograph

Model / reference

515-013100

Primary DI / UDI-DI

00382830037624

510(k) Number

K991054 ↗

FDA product code

GWF

GMDN term

Electromyograph

Device class

Class II

Regulation number

882.1870

GUDID distribution status

In Commercial Distribution

Category: Electromyograph

Other devices filed under FDA product code GWF (Stimulator, Electrical, Evoked Response).

• PROTEKTOR 32 by Natus Medical, Inc.
• BIO-LOGIC PORTABLE EVOKED RESPONSE SYSTEM by Bio-Logic Systems Corp.
• 530750 by inomed Medizintechnik GmbH
• Xltek Evoked Potential Headbox, Model EP-4-RP by Excel Tech., Ltd.
• 522624 by inomed Medizintechnik GmbH
• MagPro Cool-B70 9016E0521 by Tonica Elektronik A/S
• MagPro Accessories Flow Arm 9016B0801 by Tonica Elektronik A/S
• TN-3000 EVOKED RESPONSE SYSTEM by Tracor Northern, Inc.
• MEGA-TMS by SOTERIX MEDICAL,INC.
• TM-3600 A NEURODIAGNOSTIC SYSTEM by Tracor Northern, Inc.

• Natus Neurology S-Mjt-7522-Ll

  Class II

  FDA 510(k) K973444 Active Cleared 20 Nov 1997 GUDID on market

• Natus Neurology S-019-400500

  Class II

  FDA 510(k) K850108 Active Cleared 11 Apr 1985 GUDID on market

• Natus Neurology S035K020

  Class II

  FDA 510(k) K965065 Active Cleared 20 Jun 1997 GUDID on market

• Natus 482-649300

  Class II

  FDA 510(k) K991054 Active Cleared 3 Nov 1999 GUDID on market

See all devices from Natus Neurology Incorporated →