510(k) K904489
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