The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for P3t Abdomen.
| Device ID | K082458 |
| 510k Number | K082458 |
| Device Name: | P3T ABDOMEN |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | Fortunato Aldape |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-08-26 |
| Decision Date | 2008-10-17 |
| Summary: | summary |