EM TENS WINDOW ELECTRODES— 510(k) K864032
Substantially EquivalentElectromed Intl., Ltd.
FDA 510(k) clearance K864032 for EM TENS WINDOW ELECTRODES, Substantially Equivalent on 1986-12-22. Applicant: Electromed Intl., Ltd.. Device class: 2.
Clearance details
- Applicant
- Electromed Intl., Ltd.
- 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
- Waltham, MA, US
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More clearances from Electromed Intl., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.