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HGL — Transducer, Ultrasonic, Obstetric Class II

FDA Device Classification

Classification Details

Product Code
HGL
Device Class
Class II
Regulation Number
884.2960
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K952031advanced medical systemsULTRASOUND TRANSDUCER, MODEL US917July 18, 1995
K923335advanced medical systemsULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATIONJuly 22, 1994
K924516huntleigh technologyOP3/VP4June 28, 1993
K903348advanced technology laboratoriesULTRASONIC PULSED DOPPLER IMAGING SYSTEMOctober 22, 1990
K900966hitachi medical corp. of americaEUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBESeptember 12, 1990
K901142medical equipment resourcesMER MULTIPLANE VAGINAL PROBE (MVP)August 22, 1990
K903316ge medical systems information technologiesALOKA UST-964P-5 ENDOVAGINAL TRANSDUCERAugust 22, 1990
K900838pie medical equipmentTRANSVAGINAL TRANSDUCER ASSEMBLYMay 23, 1990
K895449ge medical systems information technologiesALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEMMarch 5, 1990
K881263multigon industriesMODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLERJanuary 5, 1990
K895647advanced technology laboratories5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCERDecember 18, 1989
K895123advanced technology laboratories5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCERNovember 13, 1989
K895026hewlett-packardHP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCERNovember 6, 1989
K894415dymaxDYMAX ENDOVAGINAL BIOPSY GUIDEOctober 25, 1989
K892070amedic usaGENERAL IVT NEEDLE GUIDE KIT, STERILESeptember 5, 1989
K881405siemens medical solutions usaSIEMENS INTRAVAGINAL TRANSDUCERAugust 2, 1988
K875371kontron instrumentsKONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEMMarch 24, 1988
K875334kontron instrumentsKONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEMMarch 24, 1988
K872265labsonicsULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE.January 4, 1988
K871856advanced technology laboratoriesANNULAR ARRAY SCANHEADAugust 28, 1987