Mytens Model: BW-TSX
FDA 510(k) clearance K171026 · decided 2017-11-01
Clearance details
- K-number
- K171026
- Device name
- Mytens Model: BW-TSX
- Applicant
- Bewell Connect Corp.
- Decision
- Substantially Equivalent
- Date received
- 2017-04-05
- Decision date
- 2017-11-01
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- NUH
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.