510(k) K881589
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 1988
- Date Received
- April 13, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Spot-Film
- Device Class
- Class II
- Regulation Number
- 892.1670
- Review Panel
- RA
- Submission Type