Submission Details
| 510(k) Number | K051178 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 09, 2005 |
| Decision Date | August 17, 2005 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
MEE-1000A NEUROMASTER
Aug 2005
Decision
100d
Days
Class 2
Risk
About This 510(k) Submission
K051178 is an FDA 510(k) clearance for the MEE-1000A NEUROMASTER, a Stimulator, Electrical, Evoked Response (Class II — Special Controls, product code GWF), submitted by Nihon Kohden America, Inc. (Foothill Ranch, US). The FDA issued a Cleared decision on August 17, 2005, 100 days after receiving the submission on May 9, 2005. 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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