TheraView TBI
FDA 510(k) K170058 · Cablon Medical B.V.
510(k) numberK170058
Submission
- Device name
- TheraView TBI
- Applicant
- Cablon Medical B.V.
Leusden, NL - Received
- January 6, 2017
- Decision date
- March 3, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was TheraView TBI cleared by the FDA?
TheraView TBI (K170058) received a 510(k) decision of Substantially Equivalent on March 3, 2017, 56 days after the submission was received.
What is the product code of K170058?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.