Best-AV2 Pro-Sport(tm)
FDA 510(k) clearance K123099 · decided 2014-05-23
Clearance details
- K-number
- K123099
- Device name
- Best-AV2 Pro-Sport(tm)
- Applicant
- Avazzia, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-10-02
- Decision date
- 2014-05-23
- Days to decision
- 598 days
- Clearance type
- Traditional
- Product code
- GZJ
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Dallas, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.