510(k) K954998
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 1996
- Date Received
- November 1, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Illuminator, Radiographic-Film
- Device Class
- Class I
- Regulation Number
- 892.1890
- Review Panel
- RA
- Submission Type