EMPI, NMS/SUE CUTANEOUS ELECTRODE— 510(k) K854513
Substantially EquivalentEmpi
FDA 510(k) clearance K854513 for EMPI, NMS/SUE CUTANEOUS ELECTRODE, Substantially Equivalent on 1985-12-06. Applicant: Empi. Device class: 2.
Clearance details
- Applicant
- Empi
- 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
- Minneapolis, MN, US
Recent devices under product code GXY
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- K261442 — Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array
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- K253237 — Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
More clearances from Empi
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