ILED

Light, Surgical, Ceiling Mounted

TRUMPF KREUZER MEDIZIN SYSTEME GMBH + CO.KG

The following data is part of a premarket notification filed by Trumpf Kreuzer Medizin Systeme Gmbh + Co.kg with the FDA for Iled.

Pre-market Notification Details

• Device ID: K061317
• 510k Number: K061317
• Device Name: ILED
• Classification: Light, Surgical, Ceiling Mounted
• Applicant: TRUMPF KREUZER MEDIZIN SYSTEME GMBH + CO.KG BENZSTRASSE 26 Munchen, DE 82178
• Contact: Willibald Hiemer
• Correspondent: Jeffrey D Rongero; UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709
• Product Code: FSY
• CFR Regulation Number: 878.4580 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2006-05-11
• Decision Date: 2006-06-22
• Summary: summary