The following data is part of a premarket notification filed by Ototronix, Llc with the FDA for Nystagram Video Nystagmography System.
| Device ID | K130201 |
| 510k Number | K130201 |
| Device Name: | NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM |
| Classification | Nystagmograph |
| Applicant | OTOTRONIX, LLC 4486 TIMBERLINE CT St Paul, MN 55127 |
| Contact | Bernard Horwath |
| Correspondent | Bernard Horwath OTOTRONIX, LLC 4486 TIMBERLINE CT St Paul, MN 55127 |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-28 |
| Decision Date | 2013-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B366VN1061 | K130201 | 000 |