SIMRITE VERIFICATION AND SIMULATION SYSTEM
FDA 510(k) clearance K885081 · decided 1989-03-22
Clearance details
- K-number
- K885081
- Device name
- SIMRITE VERIFICATION AND SIMULATION SYSTEM
- Applicant
- Haynes Radiation Ltd., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-12-09
- Decision date
- 1989-03-22
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- KPQ
- Device class
- 2
- Regulation number
- 892.5840
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Alameda, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.