VERTIGONE BPPV GOGGLE
FDA 510(k) clearance K082634 · decided 2009-04-07
Clearance details
- K-number
- K082634
- Device name
- VERTIGONE BPPV GOGGLE
- Applicant
- Vertigone, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-09-10
- Decision date
- 2009-04-07
- Days to decision
- 209 days
- Clearance type
- Traditional
- Product code
- LXV
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Woodlands, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.