COMPUTED CINETOMOGRAPHY SCANNER, MODEL C-100
FDA 510(k) clearance K828669 · decided 1983-01-14
Clearance details
- K-number
- K828669
- Device name
- COMPUTED CINETOMOGRAPHY SCANNER, MODEL C-100
- Applicant
- Imatron, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-11-30
- Decision date
- 1983-01-14
- Days to decision
- 45 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- South San Fransisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.