The following data is part of a premarket notification filed by Clearwater Clinical Limited with the FDA for Dizzyfix.
| Device ID | K081602 |
| 510k Number | K081602 |
| Device Name: | DIZZYFIX |
| Classification | Apparatus, Vestibular Analysis |
| Applicant | CLEARWATER CLINICAL LIMITED 100-111 5TH AVE. SW SUITE 258 Calgary, Alberta, CA T2p 3y6 |
| Contact | Matthew Bromwich |
| Correspondent | Matthew Bromwich CLEARWATER CLINICAL LIMITED 100-111 5TH AVE. SW SUITE 258 Calgary, Alberta, CA T2p 3y6 |
| Product Code | LXV |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-06 |
| Decision Date | 2008-09-19 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DIZZYFIX 88636497 not registered Live/Pending |
Exercore LLC 2019-09-30 |