The following data is part of a premarket notification filed by Eclipse Systems, Inc. with the FDA for Modificarion To Wackers-liu Cq Software.
| Device ID | K032500 |
| 510k Number | K032500 |
| Device Name: | MODIFICARION TO WACKERS-LIU CQ SOFTWARE |
| Classification | System, Tomography, Computed, Emission |
| Applicant | ECLIPSE SYSTEMS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson ECLIPSE SYSTEMS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-13 |
| Decision Date | 2003-08-25 |
| Summary: | summary |