LEGACY-500
FDA 510(k) clearance K111588 · decided 2012-10-26
Clearance details
- K-number
- K111588
- Device name
- LEGACY-500
- Applicant
- Mt Tables, LLC
- Decision
- Substantially Equivalent
- Date received
- 2011-06-07
- Decision date
- 2012-10-26
- Days to decision
- 507 days
- Clearance type
- Traditional
- Product code
- JFB
- Device class
- 2
- Regulation number
- 890.5880
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Aurora, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.