LOMA LINDA UNIV. PROTON BEAM THERAPY SYSTEM
FDA 510(k) clearance K872369 · decided 1988-02-22
Clearance details
- K-number
- K872369
- Device name
- LOMA LINDA UNIV. PROTON BEAM THERAPY SYSTEM
- Applicant
- Loma Linda University Medical Center
- Decision
- Substantially Equivalent
- Date received
- 1987-06-19
- Decision date
- 1988-02-22
- Days to decision
- 248 days
- Clearance type
- Traditional
- Product code
- IWM
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Loma Linda, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.