HORIZON LIGHT

Pump, Infusion

B. BRAUN MEDICAL, INC.

The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Horizon Light.

Pre-market Notification Details

• Device ID: K994375
• 510k Number: K994375
• Device Name: HORIZON LIGHT
• Classification: Pump, Infusion
• Applicant: B. BRAUN MEDICAL, INC. 1601 WALLACE DR., SUITE 150 Carrollton, TX 75006
• Contact: Gary Gulyas
• Correspondent: Gary Gulyas; B. BRAUN MEDICAL, INC. 1601 WALLACE DR., SUITE 150 Carrollton, TX 75006
• Product Code: FRN
• CFR Regulation Number: 880.5725 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-12-27
• Decision Date: 2000-03-08
• Summary: summary