WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP— 510(k) K082065
Substantially EquivalentWell-Life Healthcare Limited
FDA 510(k) clearance K082065 for WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP, Substantially Equivalent on 2009-04-10. Applicant: Well-Life Healthcare Limited. Device class: 2.
Clearance details
- Applicant
- Well-Life Healthcare Limited
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bonita Springs, FL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.