510(k) K013804
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 2001
- Date Received
- November 15, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Telemedicine, Robotic
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- SU
- Submission Type