The following data is part of a premarket notification filed by Dizzydoctor Systems, Llc with the FDA for Dizzydoctor System 1.0.0.
| Device ID | K182214 |
| 510k Number | K182214 |
| Device Name: | DizzyDoctor System 1.0.0 |
| Classification | Nystagmograph |
| Applicant | DizzyDoctor Systems, LLC 7625 Mesa College Drive, Suite 200A San Diego, CA 92111 |
| Contact | Ian Purcell |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-08-15 |
| Decision Date | 2018-09-14 |
| Summary: | summary |