Company ยท CA
Excel Tech. , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2006. Name variants (Inc, Corp, punctuation) are merged.
58510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | 15 |
| GEX | Powered Laser Surgical Instrument | 7 |
| GWF | Stimulator, Electrical, Evoked Response | 6 |
| IPF | Stimulator, Muscle, Powered | 6 |
| LIH | Interferential Current Therapy | 5 |
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | 3 |
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph | 3 |
| GWE | Stimulator, Photic, Evoked Response | 2 |
| IKN | Electromyograph, Diagnostic | 2 |
| OLV | Standard Polysomnograph With Electroencephalograph | 2 |
| ETN | Stimulator, Nerve | 1 |
| GWJ | Stimulator, Auditory, Evoked Response | 1 |
| GXY | Electrode, Cutaneous | 1 |
| GXZ | Electrode, Needle | 1 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 1 |
| ITH | Equipment, Traction, Powered | 1 |
| JXE | Device, Nerve Conduction Velocity Measurement | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 4, 2006 | K062549 | XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238 Excel Tech. , Ltd., CA | ETN |
| Aug 14, 2006 | K061269 | XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES Excel Tech. , Ltd., CA | GXY |
| Apr 21, 2006 | K053386 | XLTEK EMU40 EEG HEADBOX, MODEL PK1072 Excel Tech. , Ltd., CA | GWQ |
| Feb 7, 2006 | K053058 | XLTEK NEUROPATH, MODEL PK1070 Excel Tech. , Ltd., CA | JXE |
| Oct 28, 2005 | K052112 | XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 Excel Tech. , Ltd., CA | IKN |
| Aug 17, 2005 | K052111 | XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382 Excel Tech. , Ltd., CA | GXZ |
| Sep 16, 2004 | K042223 | XLTEK CONNEX IP HEADBOX, MODEL 1054 Excel Tech. , Ltd., CA | OMB |
| Aug 27, 2004 | K042150 | XLTEK TREX MODEL#10309 Excel Tech. , Ltd., CA | GWQ |
| Aug 6, 2004 | K040358 | XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 Excel Tech. , Ltd., CA | GWF |
| Mar 12, 2004 | K040360 | EMU128S, MODEL EX-NW-128S Excel Tech. , Ltd., CA | GWQ |
| Sep 10, 2002 | K022037 | XLTEK SLEEP SYSTEM Excel Tech. , Ltd., CA | OLV |
| Aug 13, 2002 | K021599 | 96 CHANNEL EEG HEADBOX MODEL EMU96 Excel Tech. , Ltd., CA | GWQ |
| Oct 1, 2001 | K011794 | XLTEK LED GOGGLES, MODEL LED-01 Excel Tech. , Ltd., CA | GWE |
| Apr 9, 2001 | K010086 | REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED) Excel Tech. , Ltd., CA | GWQ |
| Apr 2, 2001 | K010092 | XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED) Excel Tech. , Ltd., CA | GWF |
| Mar 26, 2001 | K010090 | XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED) Excel Tech. , Ltd., CA | GWF |
| Mar 26, 2001 | K010089 | REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED) Excel Tech. , Ltd., CA | GWQ |
| Mar 26, 2001 | K010088 | REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED) Excel Tech. , Ltd., CA | GWQ |
| Mar 19, 2001 | K010087 | XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP Excel Tech. , Ltd., CA | GWF |
| Mar 16, 2001 | K010084 | REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP Excel Tech. , Ltd., CA | GWQ |
| Mar 15, 2001 | K010085 | EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED) Excel Tech. , Ltd., CA | OMB |
| Feb 9, 2001 | K010150 | 64 CHANNEL EEG / MODEL NUMBER EX-NW-64 Excel Tech. , Ltd., CA | GWQ |
| Feb 1, 2001 | K010091 | EEG WITH VIDEO, MODEL EX-NW Excel Tech. , Ltd., CA | GWQ |
| Oct 6, 2000 | K002332 | EEG SPIKE AND EVENT DETECTOR MODULE Excel Tech. , Ltd., CA | OMB |
| Aug 31, 2000 | K000919 | 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128 Excel Tech. , Ltd., CA | GWQ |
| Jul 7, 2000 | K001166 | ULTRA V THERAPEUTIC ULTRASOUND Excel Tech. , Ltd., CA | IMG |
| Jun 30, 2000 | K001103 | WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED) Excel Tech. , Ltd., CA | GWQ |
| Jun 30, 2000 | K001101 | XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4 Excel Tech. , Ltd., CA | GWF |
| Apr 14, 2000 | K000898 | EEG WITH VIDEO, MODEL EX-NW Excel Tech. , Ltd., CA | GWQ |
| Aug 19, 1999 | K992313 | XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16 Excel Tech. , Ltd., CA | GWF |
| Aug 4, 1999 | K991903 | EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1) Excel Tech. , Ltd., CA | GWE |
| Jul 12, 1999 | K991900 | XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40 Excel Tech. , Ltd., CA | OLV |
| Oct 14, 1998 | K982479 | EXCEL AMBULATORY EEG Excel Tech. , Ltd., CA | GWQ |
| Apr 21, 1998 | K980214 | EXCEL NEURO WORKS Excel Tech. , Ltd., CA | GWQ |
| Jan 30, 1998 | K972157 | EXCEL AV STIM 1000 Excel Tech. , Ltd., CA | GWJ |
| Mar 27, 1996 | K960489 | ULTRA IV Excel Tech. , Ltd., CA | IPF |
| Mar 27, 1996 | K960096 | ULTRA III Excel Tech. , Ltd., CA | IPF |
| Mar 22, 1996 | K955860 | MULTI III, IV Excel Tech. , Ltd., CA | LIH |
| Mar 22, 1996 | K955387 | ISOTRON III, ISOTRON IV Excel Tech. , Ltd., CA | LIH |
| Nov 7, 1995 | K941144 | EXCEL EMG Excel Tech. , Ltd., CA | IKN |
| May 3, 1995 | K941815 | ISOTRON III Excel Tech. , Ltd., CA | LIH |
| Jun 7, 1994 | K940200 | EXCEL TX Excel Tech. , Ltd., CA | ITH |
| Mar 1, 1994 | K932730 | EXCEL'S EST-30 HO:YAG LASER SYSTEM Excel Tech. , Ltd. | GEX |
| Jun 25, 1993 | K931051 | MODEL 110 ND:YAG LASER Excel Tech. , Ltd. | GEX |
| Mar 9, 1993 | K923076 | ULTRA SX Excel Tech. , Ltd., CA | IMI |
| Mar 9, 1993 | K921952 | ULTRA III Excel Tech. , Ltd., CA | IMG |
| Jan 15, 1993 | K924729 | EXCEL TRIPULSE MODEL3000 Excel Tech. , Ltd. | GEX |
| Aug 26, 1992 | K921954 | ISOTRON III Excel Tech. , Ltd., CA | LIH |
| Aug 26, 1992 | K921953 | MULTI III Excel Tech. , Ltd., CA | LIH |
| Jul 8, 1992 | K922375 | EXCEL DUOPULSE MODEL 3000 COMBINATION HO/ER:YAG Excel Tech. , Ltd. | GEX |
Newest 50 of 58.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||