510(k) K012947
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 2001
- Date Received
- September 4, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type