XLTEK NEUROPATH, MODEL PK1070— 510(k) K053058
Substantially EquivalentExcel Tech. , Ltd.
FDA 510(k) clearance K053058 for XLTEK NEUROPATH, MODEL PK1070, Substantially Equivalent on 2006-02-07. Applicant: Excel Tech. , Ltd.. Device class: 2.
Clearance details
- Applicant
- Excel Tech. , Ltd.
- Product code
- Code JXE
- Device class
- Class 2
- Regulation
- 21 CFR 882.1550
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oakville, CA
Recent devices under product code JXE
view allMore clearances from Excel Tech. , Ltd.
view all- K062549 — XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238
- K061269 — XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES
- K053386 — XLTEK EMU40 EEG HEADBOX, MODEL PK1072
- 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.