510(k) K973115
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 1997
- Date Received
- August 20, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Illuminator, Radiographic-Film
- Device Class
- Class I
- Regulation Number
- 892.1890
- Review Panel
- RA
- Submission Type