The following data is part of a premarket notification filed by Olea Medical with the FDA for Perfscape V2.0.
Device ID | K111161 |
510k Number | K111161 |
Device Name: | PERFSCAPE V2.0 |
Classification | System, Image Processing, Radiological |
Applicant | OLEA MEDICAL 611 WEST 5TH STREET THIRD FLOOR Austin, TX 78701 |
Contact | Kristi Gusman |
Correspondent | Kristi Gusman OLEA MEDICAL 611 WEST 5TH STREET THIRD FLOOR Austin, TX 78701 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2011-04-25 |
Decision Date | 2011-11-04 |
Summary: | summary |