510(k) K940540
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 1994
- Date Received
- February 7, 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