FDA 510(k), K160327, ALADDIN HW3.0

510(K) Number: K160327
Device Name: ALADDIN HW3.0
Manufacturer: Silvia Fantechi
Device Classification Name: Biomicroscope, Slit-Lamp, Ac-Powered
Regulation Number: HJO
Classification Product Code: KXA
Date Received: 02/05/2016
Decision Date: 10/05/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic

707 pages (2,140 of 2,847 original pages are fully redacted)