510(k) K970886

HANAULUX BLUE 80 HOSPITAL by Heraeus Med GmbH — Product Code FSS

K970886 is an FDA 510(k) premarket notification submitted by Heraeus Med GmbH for the device "HANAULUX BLUE 80 HOSPITAL". The FDA issued a decision of Substantially Equivalent on April 16, 1997. The device falls under product code FSS (Light, Surgical, Floor Standing), a Class II device regulated under 21 CFR 878.4580. Heraeus Med GmbH has at least 2 other 510(k) clearances on record.