ELECTRODE ARRAY CAP— 510(k) K071446
Substantially EquivalentElectrode Arrays
FDA 510(k) clearance K071446 for ELECTRODE ARRAY CAP, Substantially Equivalent on 2008-07-02. Applicant: Electrode Arrays. Device class: 2.
Clearance details
- Applicant
- Electrode Arrays
- 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
- Abbreviated
- Location
- El Paso, TX, US
Recent devices under product code GXY
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- K261442 — Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array
- K261522 — BioWave BioWraps
- K253237 — Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
Data sourced from openFDA. This site is unofficial and independent of the FDA.