FDA 510(k) Applications Submitted by GEORGE MYERS

FDA 510(k) Number Submission Date Device Name Applicant
K990064 01/08/1999 DI-RHEX OPHTHALMIC DIATHERMY SYSTEM OPHTHALMIC TECHNOLOGIES, INC.
K080119 01/17/2008 CLEARSCAN ESI, INC.
K040313 02/09/2004 HRV TOOLS DEL MAR REYNOLDS MEDICAL, LTD.
K040373 02/17/2004 KERATO ANALYZER (EKA) KONAN MEDICAL, INC.
K000554 02/18/2000 POCKET ULTRASONIC OPHTHALMIC PACHYMETER, BIOMETRY TRANSDUCER FOR POCKET QUANTEL MEDICAL
K040562 03/03/2004 LIFECLINIC, MODEL 2400 LIFECLINIC INTERNATIONAL, INC.
K000775 03/09/2000 HEART 2005 AEROTEL MEDICAL SYSTEMS (1998) LTD.
K060626 03/09/2006 VUMAX SONOMED, INC.
K030770 03/11/2003 OTI SCAN WITH TRANSDUCERS OPHTHALMIC TECHNOLOGIES, INC.
K010739 03/12/2001 WATCH-PAT 100 ITAMAR MEDICAL (C.M.) 1997 LTD.
K070669 03/12/2007 IOL INJECTOR SET MEDICEL AG
K030825 03/14/2003 MPM-NET AEROTEL MEDICAL SYSTEMS (1998) LTD.
K040668 03/15/2004 E-Z SCAN AB5500+ SONOMED, INC.
K070776 03/21/2007 SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR QUANTEL MEDICAL
K001025 03/30/2000 LIFECARD CF COMPACT RECORDER REYNOLDS MEDICAL LTD.
K040837 03/31/2004 MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE MEDICEL AG
K971229 04/02/1997 CAPNOXYGEN MASK MEDSYS, INC.
K961362 04/09/1996 AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACE AEROTEL, LTD.
K991211 04/09/1999 EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM REYNOLDS MEDICAL LTD.
K951902 04/24/1995 PATHFINDER 700 HOLTER ANALYZER REYNOLDS MEDICAL LTD.
K011345 05/02/2001 CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM REYNOLDS MEDICAL LTD.
K031391 05/02/2003 HF MODULE WITH TRANSDUCERS OPHTHALMIC TECHNOLOGIES, INC.
K021447 05/06/2002 TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREMENT SYSTEM AEROTEL MEDICAL SYSTEMS (1998) LTD.
K011418 05/09/2001 ULTRAGUIDE MR-GUIDE 3000 ULTRAGUIDE LTD.
K021683 05/22/2002 CINESCAN S QUANTEL MEDICAL
K051544 06/10/2005 VITALCAREGIVING SYSTEM ADVANCED MONITORING CAREGIVING INC.
K011837 06/12/2001 LIFECARD CF 7 DAY REYNOLDS MEDICAL LTD.
K982090 06/15/1998 PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM PACEART, INC.
K081797 06/25/2008 IMAGE STORAGE SYSTEM, MODEL KSS-400 KONAN MEDICAL, INC.
K022073 06/26/2002 HEARTLINE RECEIVING STATION AEROTEL MEDICAL SYSTEMS (1998) LTD.
K092023 07/06/2009 NAVIJECT SUB2-1P, MODEL: LP604430 MEDICEL AG
K041854 07/08/2004 MPM SYSTEM AEROTEL MEDICAL SYSTEMS, LTD.
K051851 07/08/2005 AVISO OPHTHALMIC ULTRASOUND SYSTEM QUANTEL MEDICAL
K081946 07/08/2008 SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR QUANTEL MEDICAL
K972649 07/15/1997 CARDIOCALL CARDIAC EVENT RECORDER REYNOLDS MEDICAL LTD.
K022354 07/19/2002 ULTRAGUIDE CTG 2000SA ULTRAGUIDE LTD.
K051960 07/19/2005 CARDIONAVIGATOR + DEL MAR REYNOLDS MEDICAL, LTD.
K002239 07/24/2000 SIGMA 110/330 DIAGNOSTIC ULTRASOUND SYSTEM KONTRON MEDICAL SYSTEMS SAS
K002258 07/25/2000 ULTRAGUIDE CT-GUIDE 1010 ULTRAGUIDE LTD.
K012407 07/30/2001 PACEART TX3 CARDIAC EVENT RECORDER PACEART, INC.
K032422 08/05/2003 EUSOL-C AL.CHI.MI.A
K062315 08/09/2006 SUPERDIMENSION/BRONCHUS PREMIUM 2 SUPERDIMENSION, LTD.
K953762 08/11/1995 HEART 400 ECG TRANSMITTER AEROTEL, LTD.
K062397 08/16/2006 SENTINEL DEL MAR REYNOLDS MEDICAL, LTD.
K052260 08/19/2005 SUPERDIMENSION/BRONCHUS 4.1 SUPERDIMENSION, LTD.
K082380 08/19/2008 VICARDIO 12B ENERGY-LAB TECHNOLOGIES GMBH
K973141 08/21/1997 HEART ACCESS PLUS CARDIAC EVENT RECORDER PACEART, INC.
K062469 08/24/2006 VOYAGER 12 DEL MAR REYNOLDS MEDICAL, LTD.
K032736 09/04/2003 HEART 2006 AEROTEL MEDICAL SYSTEMS (1998) LTD.
K042438 09/08/2004 SUPERDIMENSION/BRONCHUS SUPERDIMENSION, LTD.
K062763 09/15/2006 NONCON ROBO PACHY F&A KONAN MEDICAL, INC.
K013150 09/20/2001 MR-GUIDE 2000 ULTRAGUIDE LTD.
K003004 09/25/2000 OSCAR 2, MODEL 222 SUNTECH MEDICAL INSTRUMENTS, INC.
K023227 09/27/2002 USG 2000SA ULTRAGUIDE LTD.
K082893 09/30/2008 PRAGER SHELL ESI, INC.
K063008 10/02/2006 HEALTH CHECK KIOSK XPEREX CORPORATION
K042745 10/04/2004 LIFESCREEN APNEA DEL MAR REYNOLDS MEDICAL, INC.
K013367 10/10/2001 CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH REYNOLDS MEDICAL LTD.
K023418 10/11/2002 HEARTONE EVENT RECORDER AND TRANSMITTER AEROTEL MEDICAL SYSTEMS (1998) LTD.
K052852 10/11/2005 SUPERDIMENSION/BRONCHUS PREMIUM SUPERDIMENSION, LTD.
K052891 10/13/2005 HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM HAWKEN INDUSTRIES
K042885 10/19/2004 OCT-OPTHALMOSCOPE OPHTHALMIC TECHNOLOGIES, INC.
K983717 10/21/1998 BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM AEROTEL MEDICAL SYSTEMS (1998) LTD.
K073066 10/30/2007 308 DERMATOLOGICAL EXCIMER SYSTEM QUANTEL MEDICAL, INC.
K073053 10/30/2007 COLPO-MASTER UNITED PRODUCTS & INSTRUMENTS, INC.
K993674 11/01/1999 POCKET ULTRASONIC PACHYMETER QUANTEL MEDICAL
K983945 11/05/1998 CORTEX DERMASCAN C ULTRASONIC SYSTEM CORTEX TECHNOLOGY APS
K073196 11/13/2007 MASTER-VU SONOMED, INC.
K053209 11/16/2005 TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM SUNTECH MEDICAL, INC.
K974522 12/02/1997 3D I-SCAN OPHTHALMIC TECHNOLOGIES, INC.
K063617 12/05/2006 EUSOL-C AL.CHI.MI.A
K024283 12/23/2002 CARDIODIRECT, MODELS 12M, 12I, 12S REYNOLDS MEDICAL LTD.
K980144 01/15/1998 HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER AEROTEL, LTD.
K010156 01/16/2001 SLEEP PAT 200 DEVICE ITAMAR MEDICAL (C.M.) 1997 LTD.
K980357 01/29/1998 KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER KONAN, INC.
K974432 11/24/1997 ULTRAGUIDE 1000 ULTRAGUIDE LTD.
K024114 12/13/2002 A-SCAN 100 OPHTHALMIC TECHNOLOGIES, INC.


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