510(k) K872369
K872369 is an FDA 510(k) premarket notification submitted by Loma Linda University Medical Center for the device "LOMA LINDA UNIV. PROTON BEAM THERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on February 22, 1988. The device falls under product code IWM (Synchrotron, Medical), a Class II device regulated under 21 CFR 892.5050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 1988
- Date Received
- June 19, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Synchrotron, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type