NeuroProbe Shielded

• FDA 510(k) K120098 decided 12 Jun 2012 Active
• FDA GUDID UDI-DI 07290014954335 listed 24 Sep 2016 Listed

1. 12 Jun 2012 Cleared FDA 510(k) K120098
2. 24 Sep 2016 Listed FDA GUDID 07290014954335

Trade name

NeuroProbe

Generic name

Depth electrode

Model / Ref / Catalog

Shielded, STR-007080-00

Primary DI / UDI-DI

07290014954335

510(k) Number

K120098 ↗

FDA product code

GZL

GMDN term

Depth electrode

Device class

Class II

Regulation number

882.1330

GUDID distribution status

In Commercial Distribution

MRI safety

MR Unsafe

Category: Depth electrode

Other devices filed under FDA product code GZL (Electrode, Depth).

• DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES by Ad-Tech Medical Instrument Corp.
• Anchor Bolt (as an accessory to Depth Electrodes) by Ad-Tech Medical Instrument Corp.
• PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES by Pmt Corp.
• Resident Expert Kinetic Testing Motion Detector C0259-00811 by FHC, INC.
• iCE-SG Subcutaneous Electrode Arrays by Ice Neurosystems, Inc.
• LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM by Alpine Biomed ApS
• MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000) by Microrecording Systems Consultants, LLC
• GUIDELINE SYSTEM by Axon Instruments, Inc.
• microTargeting™ Electrode Sterilization Tray 67-00-1-00704 by FHC, INC.
• PMT DEPTHALON DEPTH CORTICOGRAPHY ELEC by Progress Mankind Technology

• HaGuide Software

  Class II

  CE/MDR FDA 510(k) K220553 Active Cleared 16 Sep 2022 +1authorizations

• Sterile electrode's cable

  Class II

  FDA 510(k) K120098 Active Cleared 12 Jun 2012 GUDID on market

• NeuroProbe Shielded

  Class II

  FDA 510(k) K120098 Active Cleared 12 Jun 2012 GUDID on market

• NeuroProbe Non-shielded

  Class II

  FDA 510(k) K120098 Active Cleared 12 Jun 2012 GUDID on market

See all devices from Alpha Omega Engineering Corp. →