NIM 3.0

Stimulator, Electrical, Evoked Response

MEDTRONIC XOMED, INC.

The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Nim 3.0.

Pre-market Notification Details

• Device ID: K083124
• 510k Number: K083124
• Device Name: NIM 3.0
• Classification: Stimulator, Electrical, Evoked Response
• Applicant: MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216
• Contact: Jayme Wilson
• Correspondent: Jayme Wilson; MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216
• Product Code: GWF
• CFR Regulation Number: 882.1870 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-10-22
• Decision Date: 2009-02-27
• Summary: summary

NIH GUDID Devices

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