510(k) K895799
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 1990
- Date Received
- September 28, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scanner, Rectilinear, Nuclear
- Device Class
- Class I
- Regulation Number
- 892.1300
- Review Panel
- RA
- Submission Type