The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Modification To: Multirate Infusor Sv )with And Without Pcm), Multirate Infusor Lv (with And Without Pcm).
| Device ID | K051253 |
| 510k Number | K051253 |
| Device Name: | MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM) |
| Classification | Pump, Infusion, Pca |
| Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Contact | Nanette Hedden |
| Correspondent | Nanette Hedden BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Product Code | MEA |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-16 |
| Decision Date | 2005-07-15 |
| Summary: | summary |