FDA 510(k), K102130, TENZING SYSTEM

510(K) Number: K102130
Device Name: TENZING SYSTEM
Manufacturer: AHAVA STEIN
Device Classification Name: Neurological Stereotaxic Instrument
Regulation Number: HAW
Classification Product Code: 07/29/2010
Date Received: 08/26/2010
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology