1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM
FDA 510(k) clearance K123272 · decided 2013-03-28
Clearance details
- K-number
- K123272
- Device name
- 1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM
- Applicant
- Neocoil, LLC
- Decision
- Substantially Equivalent
- Date received
- 2012-10-19
- Decision date
- 2013-03-28
- Days to decision
- 160 days
- Clearance type
- Abbreviated
- Product code
- MOS
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Pewaukee, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.