Excel Tech. , Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
58
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K062549XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238October 4, 2006
K061269XLTEK CLEAN SIGNAL ADHESIVE ELECTRODESAugust 14, 2006
K053386XLTEK EMU40 EEG HEADBOX, MODEL PK1072April 21, 2006
K053058XLTEK NEUROPATH, MODEL PK1070February 7, 2006
K052112XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059October 28, 2005
K052111XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382August 17, 2005
K042223XLTEK CONNEX IP HEADBOX, MODEL 1054September 16, 2004
K042150XLTEK TREX MODEL#10309August 27, 2004
K040358XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248August 6, 2004
K040360EMU128S, MODEL EX-NW-128SMarch 12, 2004
K022037XLTEK SLEEP SYSTEMSeptember 10, 2002
K02159996 CHANNEL EEG HEADBOX MODEL EMU96August 13, 2002
K011794XLTEK LED GOGGLES, MODEL LED-01October 1, 2001
K010086REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED)April 9, 2001
K010092XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)April 2, 2001
K010090XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED)March 26, 2001
K010089REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED)March 26, 2001
K010088REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED)March 26, 2001
K010087XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RPMarch 19, 2001
K010084REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RPMarch 16, 2001