Submission Details
| 510(k) Number | K083124 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 22, 2008 |
| Decision Date | February 27, 2009 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
NIM 3.0
Feb 2009
Decision
128d
Days
Class 2
Risk
About This 510(k) Submission
K083124 is an FDA 510(k) clearance for the NIM 3.0, a Stimulator, Electrical, Evoked Response (Class II — Special Controls, product code GWF), submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on February 27, 2009, 128 days after receiving the submission on October 22, 2008. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1870.
Device Classification
| Product Code | GWF — Stimulator, Electrical, Evoked Response |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.1870 |
Manufacturer
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