The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Intermate Xlv Elastomeric Infusion System.
| Device ID | K943664 |
| 510k Number | K943664 |
| Device Name: | INTERMATE XLV ELASTOMERIC INFUSION SYSTEM |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | BAXTER HEALTHCARE CORP. RTE. 120 AND WILSON RD. Round Lake, IL 60073 |
| Contact | Patricia S Barsanti |
| Correspondent | Patricia S Barsanti BAXTER HEALTHCARE CORP. RTE. 120 AND 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 | 1994-07-28 |
| Decision Date | 1994-11-03 |