510(k) K844247
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 1985
- Date Received
- November 1, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Block, Test, Ultrasonic Scanner Calibration
- Device Class
- Class I
- Regulation Number
- 882.1925
- Review Panel
- NE
- Submission Type