The following data is part of a premarket notification filed by Natus Neurology Incorporated with the FDA for Synergy Focus Desktop Version; Synergy Focus Laptop Version.
| Device ID | K130346 |
| 510k Number | K130346 |
| Device Name: | SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | NATUS NEUROLOGY INCORPORATED 1850 DEMING WAY Middleton, WI 53562 -0000 |
| Contact | Shane T Sawall |
| Correspondent | Shane T Sawall NATUS NEUROLOGY INCORPORATED 1850 DEMING WAY Middleton, WI 53562 -0000 |
| Product Code | GWF |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWJ |
| Subsequent Product Code | GXP |
| Subsequent Product Code | IKN |
| Subsequent Product Code | JXE |
| Subsequent Product Code | OLT |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-11 |
| Decision Date | 2013-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830043472 | K130346 | 000 |
| 00382830033534 | K130346 | 000 |
| 00382830031660 | K130346 | 000 |
| 00382830059220 | K130346 | 000 |
| 00382830059213 | K130346 | 000 |
| 00382830058094 | K130346 | 000 |
| 00382830059916 | K130346 | 000 |
| 00382830059909 | K130346 | 000 |