OLEA SPHERE
System, Image Processing, Radiological
OLEA MEDICAL
The following data is part of a premarket notification filed by Olea Medical with the FDA for Olea Sphere.
Pre-market Notification Details
| Device ID | K132095 |
| 510k Number | K132095 |
| Device Name: | OLEA SPHERE |
| Classification | System, Image Processing, Radiological |
| Applicant | OLEA MEDICAL 93 AVENUE DES SORBIERS ZONE ATHELIA IV La Ciotat, FR 13600 |
| Contact | Caroline Lene |
| Correspondent | Caroline Lene OLEA MEDICAL 93 AVENUE DES SORBIERS ZONE ATHELIA IV La Ciotat, FR 13600 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-08 |
| Decision Date | 2013-12-26 |
| Summary: | summary |
Trademark Results [OLEA SPHERE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OLEA SPHERE 79136687 4578098 Live/Registered |
OLEA MEDICAL 2013-03-18 |
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