Submission Details
| 510(k) Number | K200759 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 24, 2020 |
| Decision Date | October 28, 2020 |
| Days to Decision | 218 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
NIM Vital, Nerve Integrity Monitor
Oct 2020
Decision
218d
Days
Class 2
Risk
About This 510(k) Submission
K200759 is an FDA 510(k) clearance for the NIM Vital, Nerve Integrity Monitor, 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 October 28, 2020, 218 days after receiving the submission on March 24, 2020. 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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