The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Ipump Pain Management System, Model 2l3107, 2l3107k.
| Device ID | K052973 |
| 510k Number | K052973 |
| Device Name: | IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K |
| Classification | Pump, Infusion |
| Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Contact | John Manarik |
| Correspondent | John Manarik BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-24 |
| Decision Date | 2007-01-25 |
| Summary: | summary |