510(k) K030487
K030487 is an FDA 510(k) premarket notification submitted by Ralco S.R.L. for the device "R 72". The FDA issued a decision of Substantially Equivalent on August 1, 2003. The device falls under product code KPW (Device, Beam Limiting, X-Ray, Diagnostic), a Class II device regulated under 21 CFR 892.1610. Ralco S.R.L. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 2003
- Date Received
- February 14, 2003
- 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