510(k) K081602
- Device
- DIZZYFIX
- Applicant
- CLEARWATER CLINICAL LIMITED
- 510(k) number
- K081602
- Product code
- LXV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-09-19
- Date received
- 2008-06-06
- Regulation
- 510(k) Premarket Notification
- Classification name
- Apparatus, Vestibular Analysis
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Ear Nose & Throat
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MATTHEW BROMWICH
- Address
- 100-111 5th Ave. SW Suite 258 Calgary, Alberta CA T2P 3Y6 T2P 3Y6
FDA Registration Numbers#
- 3005581270
- 3027406982
- 3042618697
- 3011310592
- 3009418685
- 9612197
- 3001541016
- 3010325634
- 3017858031
- 9710051
- 3034880867
Source Documents#
Other 510(k) Records For Product Code LXV #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220231 | GyroStim | Ultrathera Technologies, Inc. | 2022-04-27 |
| K200529 | Orion | Interacoustics A/S | 2020-08-12 |
| K192652 | TRV | Interacoustics A/S | 2020-05-27 |
| K183661 | ClearEdge Balance System | Quadrant Biosciences | 2019-10-22 |
| K190735 | EQ Balance | Upright Science, Inc. | 2019-08-16 |
| K173669 | K-D Balance | King-Devick Technologies, Inc. | 2018-04-02 |
| K121590 | VESTIBULAR ANALYSIS APPARATUS | Capacity Sports, LLC | 2012-09-20 |
| K102364 | NYDIAG 200 | Interacoustics A/S | 2010-12-23 |
| K082634 | VERTIGONE BPPV GOGGLE | Vertigone, Inc. | 2009-04-07 |
| K071973 | EPLEY OMNIAX | Vesticon | 2008-06-20 |
| K070676 | KOREBALANCE (KINESTHETIC ABILITY TRAINER) | Sportkat, LLC | 2007-04-18 |
| K070085 | BALANCE REHABILITATION UNIT (BRU) | Medicaa (Uruguay) S.A. | 2007-02-26 |
| K971549 | VMT SYSTEM | Target Health, Inc. | 1998-10-05 |
| K922037 | SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR | Micromedical Technologies, Inc. | 1992-10-26 |
| K911795 | KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000) | Breg, Inc. | 1991-11-19 |
Legacy Summary#
summary
FDA Review#
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