MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM
FDA 510(k) clearance K020069 · decided 2002-03-18
Clearance details
- K-number
- K020069
- Device name
- MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM
- Applicant
- Medtronic Midas Rex
- Decision
- Substantially Equivalent
- Date received
- 2002-01-09
- Decision date
- 2002-03-18
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- HBB
- Device class
- 2
- Regulation number
- 882.4370
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
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