The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Baxter Sigma Spectrum Infusion Pump With Master Drug Library.
| Device ID | K133801 |
| 510k Number | K133801 |
| Device Name: | BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY |
| Classification | Pump, Infusion |
| Applicant | BAXTER HEALTHCARE CORPORATION 32650 N. WILSON ROAD Round Lake, IL 60073 |
| Contact | Thomas Sampogna |
| Correspondent | Thomas Sampogna BAXTER HEALTHCARE CORPORATION 32650 N. WILSON ROAD Round Lake, IL 60073 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-13 |
| Decision Date | 2014-05-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00085412498683 | K133801 | 000 |