COMPUTE-RX-COMP (TM)
FDA 510(k) clearance K910367 · decided 1991-05-30
Clearance details
- K-number
- K910367
- Device name
- COMPUTE-RX-COMP (TM)
- Applicant
- Medicalibration Physics Consultant Services, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-01-29
- Decision date
- 1991-05-30
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- KPQ
- Device class
- 2
- Regulation number
- 892.5840
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Ripon, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.