510(k) K013751
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 6, 2002
- Date Received
- November 13, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Probe, Uptake, Nuclear
- Device Class
- Class I
- Regulation Number
- 892.1320
- Review Panel
- RA
- Submission Type