WiTouch Pro, WiTouch, Neubac
FDA 510(k) clearance K171599 · decided 2017-09-22
Clearance details
- K-number
- K171599
- Device name
- WiTouch Pro, WiTouch, Neubac
- Applicant
- Hollywog, LLC
- Decision
- Substantially Equivalent
- Date received
- 2017-06-01
- Decision date
- 2017-09-22
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- NUH
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Chattanooga, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.