EPLEY OMNIAX
FDA 510(k) clearance K071973 · decided 2008-06-20
Clearance details
- K-number
- K071973
- Device name
- EPLEY OMNIAX
- Applicant
- Vesticon
- Decision
- Substantially Equivalent
- Date received
- 2007-07-17
- Decision date
- 2008-06-20
- Days to decision
- 339 days
- Clearance type
- Traditional
- Product code
- LXV
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Portland, OR, US
- Third-party review
- No
- Expedited review
- No
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| VERTIGONE BPPV GOGGLE (K082634) | Vertigone, Inc. | 2009-04-07 |
| DIZZYFIX (K081602) | Clearwater Clinical Limited | 2008-09-19 |
| KOREBALANCE (KINESTHETIC ABILITY TRAINER) (K070676) | Sportkat, LLC | 2007-04-18 |
| BALANCE REHABILITATION UNIT (BRU) (K070085) | Medicaa (Uruguay) S.A. | 2007-02-26 |
Recalls involving this device
No recalls on record reference this clearance.