TENS/NMES/FES STIMULATING ELECTRODE— 510(k) K083350
Substantially EquivalentCovidien LP
FDA 510(k) clearance K083350 for TENS/NMES/FES STIMULATING ELECTRODE, Substantially Equivalent on 2009-04-21. Applicant: Covidien LP. Device class: 2.
Clearance details
- Applicant
- Covidien LP
- 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
- Mansfield, MA, US
Recent devices under product code GXY
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- K253237 — Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
More clearances from Covidien LP
view allData sourced from openFDA. This site is unofficial and independent of the FDA.