The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Syndeo Pca Syringe Pump, Model 2l3113.
| Device ID | K031566 |
| 510k Number | K031566 |
| Device Name: | SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 |
| Classification | Pump, Infusion, Pca |
| Applicant | BAXTER HEALTHCARE CORP. ONE BAXTER PKWY. Deerfield, IL 60015 |
| Contact | Jennifer M Paine |
| Correspondent | Jennifer M Paine BAXTER HEALTHCARE CORP. ONE BAXTER PKWY. Deerfield, IL 60015 |
| Product Code | MEA |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-19 |
| Decision Date | 2003-08-19 |
| Summary: | summary |