XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES— 510(k) K061269
Substantially EquivalentExcel Tech. , Ltd.
FDA 510(k) clearance K061269 for XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES, Substantially Equivalent on 2006-08-14. Applicant: Excel Tech. , Ltd.. Device class: 2.
Clearance details
- Applicant
- Excel Tech. , 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
- Oakville, CA
Recent devices under product code GXY
view all- K262654 — Dexus Prosthetic System (MSL2, MSR2)
- K260578 — Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)
- 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)
More clearances from Excel Tech. , Ltd.
view all- K062549 — XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238
- K053386 — XLTEK EMU40 EEG HEADBOX, MODEL PK1072
- K053058 — XLTEK NEUROPATH, MODEL PK1070
- K052112 — XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059
- K052111 — XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382
Data sourced from openFDA. This site is unofficial and independent of the FDA.