510(k) K940112
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 11, 1995
- Date Received
- January 10, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Processor, Radiographic-Film, Automatic
- Device Class
- Class II
- Regulation Number
- 892.1900
- Review Panel
- RA
- Submission Type