MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700
FDA 510(k) clearance K090112 · decided 2009-03-26
Clearance details
- K-number
- K090112
- Device name
- MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700
- Applicant
- Medtronic Powered Surgical Solutions
- Decision
- Substantially Equivalent
- Date received
- 2009-01-16
- Decision date
- 2009-03-26
- Days to decision
- 69 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.