Excel Tech., Ltd.
Oakville, CA
Excel Tech. , Ltd. appears in FDA device records in Oakville, CA. FDA records list 58 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 58
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 58FDA records hold 58 510(k) clearances for Excel Tech., Ltd. between 1985 and 2006. The busiest year on record is 2001, with 11. The most recent is 2006, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1990 | 4 |
| 1992 | 6 |
| 1993 | 4 |
| 1994 | 2 |
| 1995 | 2 |
| 1996 | 4 |
| 1998 | 3 |
| 1999 | 3 |
| 2000 | 6 |
| 2001 | 11 |
| 2002 | 2 |
| 2004 | 4 |
| 2005 | 2 |
| 2006 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K062549 | XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238 | ETN | Substantially Equivalent | |
| K061269 | XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES | GXY | Substantially Equivalent | |
| K053386 | XLTEK EMU40 EEG HEADBOX, MODEL PK1072 | GWQ | Substantially Equivalent | |
| K053058 | XLTEK NEUROPATH, MODEL PK1070 | JXE | Substantially Equivalent | |
| K052112 | XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 | IKN | Substantially Equivalent | |
| K052111 | XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382 | GXZ | Substantially Equivalent | |
| K042223 | XLTEK CONNEX IP HEADBOX, MODEL 1054 | OMB | Substantially Equivalent | |
| K042150 | XLTEK TREX MODEL#10309 | GWQ | Substantially Equivalent | |
| K040358 | XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 | GWF | Substantially Equivalent | |
| K040360 | EMU128S, MODEL EX-NW-128S | GWQ | Substantially Equivalent | |
| K022037 | XLTEK SLEEP SYSTEM | OLV | Substantially Equivalent | |
| K021599 | 96 CHANNEL EEG HEADBOX MODEL EMU96 | GWQ | Substantially Equivalent | |
| K011794 | XLTEK LED GOGGLES, MODEL LED-01 | GWE | Substantially Equivalent | |
| K010086 | REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED) | GWQ | Substantially Equivalent | |
| K010092 | XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED) | GWF | Substantially Equivalent | |
| K010090 | XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED) | GWF | Substantially Equivalent | |
| K010089 | REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED) | GWQ | Substantially Equivalent | |
| K010088 | REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED) | GWQ | Substantially Equivalent | |
| K010087 | XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP | GWF | Substantially Equivalent | |
| K010084 | REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP | GWQ | Substantially Equivalent | |
| K010085 | EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED) | OMB | Substantially Equivalent | |
| K010150 | 64 CHANNEL EEG / MODEL NUMBER EX-NW-64 | GWQ | Substantially Equivalent | |
| K010091 | EEG WITH VIDEO, MODEL EX-NW | GWQ | Substantially Equivalent | |
| K002332 | EEG SPIKE AND EVENT DETECTOR MODULE | OMB | Substantially Equivalent | |
| K000919 | 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128 | GWQ | Substantially Equivalent | |
| K001166 | ULTRA V THERAPEUTIC ULTRASOUND | IMG | Substantially Equivalent | |
| K001103 | WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED) | GWQ | Substantially Equivalent | |
| K001101 | XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4 | GWF | Substantially Equivalent | |
| K000898 | EEG WITH VIDEO, MODEL EX-NW | GWQ | Substantially Equivalent | |
| K992313 | XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16 | GWF | Substantially Equivalent | |
| K991903 | EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1) | GWE | Substantially Equivalent | |
| K991900 | XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40 | OLV | Substantially Equivalent | |
| K982479 | EXCEL AMBULATORY EEG | GWQ | Substantially Equivalent | |
| K980214 | EXCEL NEURO WORKS | GWQ | Substantially Equivalent | |
| K972157 | EXCEL AV STIM 1000 | GWJ | Substantially Equivalent | |
| K960489 | ULTRA IV | IPF | Substantially Equivalent for Some Indications | |
| K960096 | ULTRA III | IPF | Substantially Equivalent for Some Indications | |
| K955860 | MULTI III, IV | LIH | Substantially Equivalent for Some Indications | |
| K955387 | ISOTRON III, ISOTRON IV | LIH | Substantially Equivalent for Some Indications | |
| K941144 | EXCEL EMG | IKN | Substantially Equivalent | |
| K941815 | ISOTRON III | LIH | Substantially Equivalent for Some Indications | |
| K940200 | EXCEL TX | ITH | Substantially Equivalent | |
| K932730 | EXCEL'S EST-30 HO:YAG LASER SYSTEM | GEX | Substantially Equivalent | |
| K931051 | MODEL 110 ND:YAG LASER | GEX | Substantially Equivalent | |
| K923076 | ULTRA SX | IMI | Substantially Equivalent | |
| K921952 | ULTRA III | IMG | Substantially Equivalent | |
| K924729 | EXCEL TRIPULSE MODEL3000 | GEX | Substantially Equivalent | |
| K921954 | ISOTRON III | LIH | Substantially Equivalent | |
| K921953 | MULTI III | LIH | Substantially Equivalent | |
| K922375 | EXCEL DUOPULSE MODEL 3000 COMBINATION HO/ER:YAG | GEX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph
- JXEDevice, Nerve Conduction Velocity Measurement
- GXYElectrode, Cutaneous
- GXZElectrode, Needle
- IKNElectromyograph, Diagnostic
- ITHEquipment, Traction, Powered
- GWQFull-Montage Standard Electroencephalograph
- LIHInterferential Current Therapy
- GEXPowered Laser Surgical Instrument
- OLVStandard Polysomnograph With Electroencephalograph
- GWJStimulator, Auditory, Evoked Response
- GWFStimulator, Electrical, Evoked Response
- IPFStimulator, Muscle, Powered
- ETNStimulator, Nerve
- GWEStimulator, Photic, Evoked Response
- IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
- IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain