NeuroProbe MF-Shielded

• FDA 510(k) K052527 decided 12 Apr 2006 Active
• FDA GUDID UDI-DI 07290016450583 listed 24 Sep 2016 Listed

1. 12 Apr 2006 Cleared FDA 510(k) K052527
2. 24 Sep 2016 Listed FDA GUDID 07290016450583

Trade name

NeuroProbe

Generic name

Depth electrode

Model / Ref / Catalog

MF-Shielded, 366-090244-00

Primary DI / UDI-DI

07290016450583

510(k) Number

K052527 ↗

FDA product code

GZL

GMDN term

Depth electrode

Device class

Class II

Regulation number

882.1330

GUDID distribution status

In Commercial Distribution

Sterilisation method

Moist Heat or Steam Sterilization

MRI safety

MR Unsafe

Category: Depth electrode

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• HaGuide Software

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• Sterile electrode's cable

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  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. →