The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Infusor Sv, Infusor Lv, Baxter Pain Management System.
| Device ID | K002380 |
| 510k Number | K002380 |
| Device Name: | INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM |
| Classification | Pump, Infusion |
| Applicant | BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
| Contact | Vicki L Drews |
| Correspondent | Vicki L Drews BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-04 |
| Decision Date | 2000-09-05 |