The following data is part of a premarket notification filed by Vanderbilt University with the FDA for Olinda/exm.
| Device ID | K033960 |
| 510k Number | K033960 |
| Device Name: | OLINDA/EXM |
| Classification | Camera, Scintillation (gamma) |
| Applicant | VANDERBILT UNIVERSITY 1161 21ST AVENUE SOUTH Nashville, TN 37232 -2675 |
| Contact | Michael Stabin |
| Correspondent | Michael Stabin VANDERBILT UNIVERSITY 1161 21ST AVENUE SOUTH Nashville, TN 37232 -2675 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-22 |
| Decision Date | 2004-06-15 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OLINDA/EXM 76552985 2957815 Live/Registered |
The Vanderbilt University 2003-10-21 |