The following data is part of a premarket notification filed by Eb Neuro, S.p.a. with the FDA for Stm 9000 Basic, Stm 9000 Standard, Stm 9000 Fast, Stm 9000 Ultra-fast.
| Device ID | K150220 |
| 510k Number | K150220 |
| Device Name: | STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | EB NEURO, S.P.A. VIA PIETRO FANFANI 97/A Florence, IT 50127 |
| Contact | Christiano Pineider |
| Correspondent | Allison Scott Navigant Consulting, Inc 9001 Wesleyan Road, Suite 200 Indianapolis, IN 46268 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-30 |
| Decision Date | 2015-08-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056446900871 | K150220 | 000 |
| 08056446900598 | K150220 | 000 |
| 08056446900581 | K150220 | 000 |
| 08056446900567 | K150220 | 000 |
| 08056446900550 | K150220 | 000 |
| 08056446900543 | K150220 | 000 |
| 08056446900536 | K150220 | 000 |
| 08056446900529 | K150220 | 000 |
| 08056446900512 | K150220 | 000 |
| 08056446900505 | K150220 | 000 |
| 08056446900499 | K150220 | 000 |
| 08056446900482 | K150220 | 000 |
| 08056446900475 | K150220 | 000 |
| 08056446900468 | K150220 | 000 |
| 08056446900451 | K150220 | 000 |
| 08056446900444 | K150220 | 000 |
| 08056446900604 | K150220 | 000 |
| 08056446900611 | K150220 | 000 |
| 08056446900864 | K150220 | 000 |
| 08056446900857 | K150220 | 000 |
| 08056446900840 | K150220 | 000 |
| 08056446900833 | K150220 | 000 |
| 08056446900826 | K150220 | 000 |
| 08056446900819 | K150220 | 000 |
| 08056446900802 | K150220 | 000 |
| 08056446900796 | K150220 | 000 |
| 08056446900789 | K150220 | 000 |
| 08056446900772 | K150220 | 000 |
| 08056446900765 | K150220 | 000 |
| 08056446900758 | K150220 | 000 |
| 08056446900741 | K150220 | 000 |
| 08056446900635 | K150220 | 000 |
| 08056446900628 | K150220 | 000 |
| 08056446900437 | K150220 | 000 |