The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Singleday Infusor 2 Ml/hr (elastomeric Infusion Device) Model, Infusor Sv 5 Ml/hr (elastomeric Infusion Device) Model Cy.
| Device ID | K982102 |
| 510k Number | K982102 |
| Device Name: | SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY |
| Classification | Pump, Infusion, Elastomeric |
| 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 | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-15 |
| Decision Date | 1998-09-04 |
| Summary: | summary |