Mytens Model: BW-TSX— 510(k) K171026
Substantially EquivalentBewell Connect Corp.
FDA 510(k) clearance K171026 for Mytens Model: BW-TSX, Substantially Equivalent on 2017-11-01. Applicant: Bewell Connect Corp.. Device class: 2.
Clearance details
- Applicant
- Bewell Connect Corp.
- Product code
- Code NUH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cambridge, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.