The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Intego Pet Infusion System.
| Device ID | K080297 |
| 510k Number | K080297 |
| Device Name: | MEDRAD INTEGO PET INFUSION SYSTEM |
| Classification | Pump, Infusion |
| Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | Troy A Jack |
| Correspondent | Troy A Jack MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-04 |
| Decision Date | 2008-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616258020242 | K080297 | 000 |
| 40616258024835 | K080297 | 000 |
| 40616258021476 | K080297 | 000 |
| 40616258021773 | K080297 | 000 |
| 10616258005291 | K080297 | 000 |
| 10616258005697 | K080297 | 000 |
| 00616258008677 | K080297 | 000 |
| 00616258008684 | K080297 | 000 |
| 00616258008691 | K080297 | 000 |
| 00616258008707 | K080297 | 000 |
| 00616258008714 | K080297 | 000 |
| 00616258008721 | K080297 | 000 |
| 00616258008738 | K080297 | 000 |
| 40616258010555 | K080297 | 000 |
| 40616258024415 | K080297 | 000 |