510(k) K894742
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 1989
- Date Received
- July 17, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assembly, Tube Housing, X-Ray, Diagnostic
- Device Class
- Class I
- Regulation Number
- 892.1760
- Review Panel
- RA
- Submission Type