510(k) K942883
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 1994
- Date Received
- June 17, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Film Marking, Radiographic
- Device Class
- Class I
- Regulation Number
- 892.1640
- Review Panel
- RA
- Submission Type