510(k) K852528
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 1985
- Date Received
- June 14, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Phantom, Anthropomorphic, Radiographic
- Device Class
- Class I
- Regulation Number
- 892.1950
- Review Panel
- RA
- Submission Type