The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Infusor Patient Control Module, 2ml, Model 2c1067k.
| Device ID | K002739 |
| 510k Number | K002739 |
| Device Name: | INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K |
| Classification | Pump, Infusion, Pca |
| Applicant | BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
| Contact | Vicki Drews |
| Correspondent | Vicki Drews BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
| Product Code | MEA |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-01 |
| Decision Date | 2000-09-11 |