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 |