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FDA 510(k) & PMA Approved Devices — 58 products

Total Devices58

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K062549	XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238	ETN	2006-10-04	View
510(k)	K061269	XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES	GXY	2006-08-14	View
510(k)	K053386	XLTEK EMU40 EEG HEADBOX, MODEL PK1072	GWQ	2006-04-21	View
510(k)	K053058	XLTEK NEUROPATH, MODEL PK1070	JXE	2006-02-07	View
510(k)	K052112	XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059	IKN	2005-10-28	View
510(k)	K052111	XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382	GXZ	2005-08-17	View
510(k)	K042223	XLTEK CONNEX IP HEADBOX, MODEL 1054	OMB	2004-09-16	View
510(k)	K042150	XLTEK TREX MODEL#10309	GWQ	2004-08-27	View
510(k)	K040358	XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248	GWF	2004-08-06	View
510(k)	K040360	EMU128S, MODEL EX-NW-128S	GWQ	2004-03-12	View
510(k)	K022037	XLTEK SLEEP SYSTEM	OLV	2002-09-10	View
510(k)	K021599	96 CHANNEL EEG HEADBOX MODEL EMU96	GWQ	2002-08-13	View
510(k)	K011794	XLTEK LED GOGGLES, MODEL LED-01	GWE	2001-10-01	View
510(k)	K010086	REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED)	GWQ	2001-04-09	View
510(k)	K010092	XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)	GWF	2001-04-02	View
510(k)	K010088	REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED)	GWQ	2001-03-26	View
510(k)	K010090	XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED)	GWF	2001-03-26	View
510(k)	K010089	REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED)	GWQ	2001-03-26	View
510(k)	K010087	XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP	GWF	2001-03-19	View
510(k)	K010084	REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP	GWQ	2001-03-16	View