CHROMOPHARE

Light, Surgical, Ceiling Mounted

BERCHTOLD HOLDING GMBH

The following data is part of a premarket notification filed by Berchtold Holding Gmbh with the FDA for Chromophare.

Pre-market Notification Details

• Device ID: K922836
• 510k Number: K922836
• Device Name: CHROMOPHARE
• Classification: Light, Surgical, Ceiling Mounted
• Applicant: BERCHTOLD HOLDING GMBH LUDWIGSTALER STR. 25 Tuttlingen, DE D-78532
• Contact: David N Bulman
• Correspondent: David N Bulman; BERCHTOLD HOLDING GMBH LUDWIGSTALER STR. 25 Tuttlingen, DE D-78532
• Product Code: FSY
• CFR Regulation Number: 878.4580 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-06-12
• Decision Date: 1992-10-09