K150220 is an FDA 510(k) clearance for the STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast. This device is classified as a Stimulator, Electrical, Evoked Response (Class II - Special Controls, product code GWF).
Submitted by Eb Neuro S.P.A. (Florence, IT). The FDA issued a Cleared decision on August 19, 2015, 201 days after receiving the submission on January 30, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1870.
| 510(k) Number | K150220 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2015 |
| Decision Date | August 19, 2015 |
| Days to Decision | 201 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWF - Stimulator, Electrical, Evoked Response |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1870 |