FDA 510(k) Applications Submitted by EXCEL TECH. LTD.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K010087 |
01/11/2001 |
XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP |
EXCEL TECH. LTD. |
| K010088 |
01/11/2001 |
REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED) |
EXCEL TECH. LTD. |
| K040358 |
02/13/2004 |
XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 |
EXCEL TECH. LTD. |
| K040360 |
02/13/2004 |
EMU128S, MODEL EX-NW-128S |
EXCEL TECH. LTD. |
| K001166 |
04/10/2000 |
ULTRA V THERAPEUTIC ULTRASOUND |
EXCEL TECH. LTD. |
| K010089 |
01/11/2001 |
REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED) |
EXCEL TECH. LTD. |
| K010084 |
01/11/2001 |
REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP |
EXCEL TECH. LTD. |
| K000898 |
03/21/2000 |
EEG WITH VIDEO, MODEL EX-NW |
EXCEL TECH. LTD. |
| K000919 |
03/22/2000 |
128 CHANNEL EEG HEADBOX, MODEL EX-NW-128 |
EXCEL TECH. LTD. |
| K001101 |
04/05/2000 |
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4 |
EXCEL TECH. LTD. |
| K001103 |
04/05/2000 |
WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED) |
EXCEL TECH. LTD. |
| K002332 |
08/01/2000 |
EEG SPIKE AND EVENT DETECTOR MODULE |
EXCEL TECH. LTD. |
| K021599 |
05/15/2002 |
96 CHANNEL EEG HEADBOX MODEL EMU96 |
EXCEL TECH. LTD. |
| K960096 |
01/11/1996 |
ULTRA III |
EXCEL TECH. LTD. |
| K980214 |
01/21/1998 |
EXCEL NEURO WORKS |
EXCEL TECH. LTD. |
| K960489 |
02/02/1996 |
ULTRA IV |
EXCEL TECH. LTD. |
| K991903 |
06/04/1999 |
EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1) |
EXCEL TECH. LTD. |
| K972157 |
06/09/1997 |
EXCEL AV STIM 1000 |
EXCEL TECH. LTD. |
| K992313 |
07/09/1999 |
XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16 |
EXCEL TECH. LTD. |
| K982479 |
07/16/1998 |
EXCEL AMBULATORY EEG |
EXCEL TECH. LTD. |
| K955387 |
11/22/1995 |
ISOTRON III, ISOTRON IV |
EXCEL TECH. LTD. |
| K955860 |
12/27/1995 |
MULTI III, IV |
EXCEL TECH. LTD. |
| K991900 |
06/04/1999 |
XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40 |
EXCEL TECH. LTD. |
| K061269 |
05/05/2006 |
XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES |
EXCEL TECH. LTD. |
| K052111 |
08/04/2005 |
XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382 |
EXCEL TECH. LTD. |
| K052112 |
08/04/2005 |
XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 |
EXCEL TECH. LTD. |
| K042150 |
08/09/2004 |
XLTEK TREX MODEL#10309 |
EXCEL TECH. LTD. |
| K042223 |
08/17/2004 |
XLTEK CONNEX IP HEADBOX, MODEL 1054 |
EXCEL TECH. LTD. |
| K062549 |
08/30/2006 |
XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238 |
EXCEL TECH. LTD. |
| K053058 |
10/31/2005 |
XLTEK NEUROPATH, MODEL PK1070 |
EXCEL TECH. LTD. |
| K053386 |
12/05/2005 |
XLTEK EMU40 EEG HEADBOX, MODEL PK1072 |
EXCEL TECH. LTD. |
| K010085 |
01/11/2001 |
EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED) |
EXCEL TECH. LTD. |
| K010086 |
01/11/2001 |
REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED) |
EXCEL TECH. LTD. |
| K010090 |
01/11/2001 |
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED) |
EXCEL TECH. LTD. |
| K010091 |
01/11/2001 |
EEG WITH VIDEO, MODEL EX-NW |
EXCEL TECH. LTD. |
| K010092 |
01/11/2001 |
XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED) |
EXCEL TECH. LTD. |
| K010150 |
01/17/2001 |
64 CHANNEL EEG / MODEL NUMBER EX-NW-64 |
EXCEL TECH. LTD. |
| K011794 |
06/08/2001 |
XLTEK LED GOGGLES, MODEL LED-01 |
EXCEL TECH. LTD. |
| K022037 |
06/24/2002 |
XLTEK SLEEP SYSTEM |
EXCEL TECH. LTD. |
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