510(k) K904489

EUREKA EXTENSION CYLINDERS by Eureka X-Ray Tube Corp. — Product Code KPW

K904489 is an FDA 510(k) premarket notification submitted by Eureka X-Ray Tube Corp. for the device "EUREKA EXTENSION CYLINDERS". The FDA issued a decision of Substantially Equivalent on October 15, 1990. The device falls under product code KPW (Device, Beam Limiting, X-Ray, Diagnostic), a Class II device regulated under 21 CFR 892.1610. Eureka X-Ray Tube Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1990
Date Received
October 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Beam Limiting, X-Ray, Diagnostic
Device Class
Class II
Regulation Number
892.1610
Review Panel
RA
Submission Type