PERFSCAPE
System, Nuclear Magnetic Resonance Imaging
OLEA MEDICAL
The following data is part of a premarket notification filed by Olea Medical with the FDA for Perfscape.
Pre-market Notification Details
| Device ID | K091444 |
| 510k Number | K091444 |
| Device Name: | PERFSCAPE |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | OLEA MEDICAL 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Contact | Neal Kolber |
| Correspondent | Neal Kolber OLEA MEDICAL 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-15 |
| Decision Date | 2009-07-20 |
| Summary: | summary |
Trademark Results [PERFSCAPE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PERFSCAPE 79073281 3818624 Live/Registered |
OLEA MEDICAL 2009-05-12 |
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