510(k) K170058
K170058 is an FDA 510(k) premarket notification submitted by Cablon Medical B.V. for the device "TheraView TBI". The FDA issued a decision of Substantially Equivalent on Mar 3, 2017. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 3, 2017
- Date Received
- Jan 6, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accelerator, Linear, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type
- 510(k)