The following data is part of a premarket notification filed by Byron Medical with the FDA for Psi-tec Peristaltic Infiltration Pump.
| Device ID | K040149 |
| 510k Number | K040149 |
| Device Name: | PSI-TEC PERISTALTIC INFILTRATION PUMP |
| Classification | Pump, Infusion |
| Applicant | BYRON MEDICAL 602 W. RILLITO ST. Tucson, AZ 85705 |
| Contact | Regina S Harris |
| Correspondent | Regina S Harris BYRON MEDICAL 602 W. RILLITO ST. Tucson, AZ 85705 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-23 |
| Decision Date | 2004-06-03 |
| Summary: | summary |