The following data is part of a premarket notification filed by Olea Medical with the FDA for Perfscape.
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() PERFSCAPE 79073281 3818624 Live/Registered |
OLEA MEDICAL 2009-05-12 |