510(k) K920190
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 1992
- Date Received
- January 15, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screen, Intensifying, Radiographic
- Device Class
- Class I
- Regulation Number
- 892.1960
- Review Panel
- RA
- Submission Type