The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Pump Connectivity Interface.
Device ID | K040985 |
510k Number | K040985 |
Device Name: | PUMP CONNECTIVITY INTERFACE |
Classification | Pump, Infusion |
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 | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-04-15 |
Decision Date | 2004-11-30 |
Summary: | summary |