Neuroprobes

510(k) Number

K052527 ↗

FDA product code

GZL

FDA applicant

Alpha Omega Engineering , Ltd.

Device class

Class II

Regulation

21 CFR Part 882.1330

Advisory committee

Neurology

FDA decision

SESE Substantially Equivalent

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

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

• Wyler Sphenoidal Electrode by Ad-Tech Medical Instrument 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
• NeuroSmart with NeuroFortis Drive Headstage NSW-026010-55 by Alpha Omega Engineering Corp.
• 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.
• Foramen Ovale Electrode by Ad-Tech Medical Instrument Corp.
• PMT DEPTHALON DEPTH CORTICOGRAPHY ELEC by Progress Mankind Technology

• Neuro Omega Pro with 2 NeuroFortis Drive Headstage + 1 basic stimulation Slots

  Class IIb

  CE/MDR

• Neuro Omega with NeuroFortis Drive Headstage + 1 basic stimulation Slot

  Class IIb

  CE/MDR

• NeuroFortis Neuro Omega Drive Headstage KIT

  Class IIb

  CE/MDR

• Neuro Omega Pro with 2 AutoClavable Drive Headstages

  Class IIb

  CE/MDR

See all devices from Alpha Omega Engineering Ltd →