BRIGHTSTAR

Light, Surgical, Ceiling Mounted

HILL-ROM, INC.

The following data is part of a premarket notification filed by Hill-rom, Inc. with the FDA for Brightstar.

Pre-market Notification Details

• Device ID: K981081
• 510k Number: K981081
• Device Name: BRIGHTSTAR
• Classification: Light, Surgical, Ceiling Mounted
• Applicant: HILL-ROM, INC. 1069 STATE ROUTE 46 EAST Batesville, IN 47006
• Contact: William D Jordan
• Correspondent: William D Jordan; HILL-ROM, INC. 1069 STATE ROUTE 46 EAST Batesville, IN 47006
• Product Code: FSY
• CFR Regulation Number: 878.4580 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-03-24
• Decision Date: 1998-04-29
• Summary: summary