510(k) K945731
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 15, 1995
- Date Received
- November 22, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Generator, High-Voltage, X-Ray, Diagnostic
- Device Class
- Class I
- Regulation Number
- 892.1700
- Review Panel
- RA
- Submission Type