510(k) K954169

HANAULUX BLUE 30 & 80 by Heraeus Med GmbH — Product Code FSY

K954169 is an FDA 510(k) premarket notification submitted by Heraeus Med GmbH for the device "HANAULUX BLUE 30 & 80". The FDA issued a decision of Substantially Equivalent on February 1, 1996. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580. Heraeus Med GmbH has at least 2 other 510(k) clearances on record.