510(k) K883354

VARIABLE KV INTREX VSK 60 - 90 KVP by Keystone X-Ray, Inc. — Product Code EAP

K883354 is an FDA 510(k) premarket notification submitted by Keystone X-Ray, Inc. for the device "VARIABLE KV INTREX VSK 60 - 90 KVP". The FDA issued a decision of Substantially Equivalent on December 21, 1988. The device falls under product code EAP (Unit, X-Ray, Intraoral), a Class II device regulated under 21 CFR 872.1810. Keystone X-Ray, Inc. has at least 3 other 510(k) clearances on record.