The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Basal/bolus Infusors.
Device ID | K884505 |
510k Number | K884505 |
Device Name: | BASAL/BOLUS INFUSORS |
Classification | Pump, Infusion |
Applicant | BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
Contact | Patricia S Barsanti |
Correspondent | Patricia S Barsanti BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. 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 | 1988-10-25 |
Decision Date | 1989-07-14 |