OLEA SPHERE
FDA 510(k) clearance K132095 · decided 2013-12-26
Clearance details
- K-number
- K132095
- Device name
- OLEA SPHERE
- Applicant
- Olea Medical
- Decision
- Substantially Equivalent
- Date received
- 2013-07-08
- Decision date
- 2013-12-26
- Days to decision
- 171 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- La Ciotat, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.