BETA C COUNTER
FDA 510(k) clearance K943072 · decided 1994-09-29
Clearance details
- K-number
- K943072
- Device name
- BETA C COUNTER
- Applicant
- Capintec Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-06-28
- Decision date
- 1994-09-29
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- KPT
- Device class
- 2
- Regulation number
- 892.1360
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Pittsburgh, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.