510(k) K921355
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 1992
- Date Received
- March 20, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Collimator, X-Ray
- Device Class
- Class I
- Regulation Number
- 872.1840
- Review Panel
- RA
- Submission Type