The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Ipump Pain Management System, Model 2l3107k.
Device ID | K993387 |
510k Number | K993387 |
Device Name: | IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K |
Classification | Pump, Infusion |
Applicant | BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
Contact | Vicki L Drews |
Correspondent | Vicki L Drews BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-10-08 |
Decision Date | 1999-11-01 |
Summary: | summary |