KOALA C99 I.V. CONTROLLER

Controller, Infusion, Intravascular, Electronic

CHESEBROUGH-POND'S U.S.A. CO.

The following data is part of a premarket notification filed by Chesebrough-pond's U.s.a. Co. with the FDA for Koala C99 I.v. Controller.

Pre-market Notification Details

• Device ID: K830780
• 510k Number: K830780
• Device Name: KOALA C99 I.V. CONTROLLER
• Classification: Controller, Infusion, Intravascular, Electronic
• Applicant: CHESEBROUGH-POND'S U.S.A. CO. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: LDR
• CFR Regulation Number: 880.5725 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-03-11
• Decision Date: 1983-04-08