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510(k) K895449

Device
ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
510(k) number
K895449
Product code
HGL  
Decision
Substantially Equivalent (SESE)
Decision date
1990-03-05
Date received
1989-08-23
Regulation
884.2960
Classification name
Transducer, Ultrasonic, Obstetric
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BRIAN R BARRY
Address
61 Barnes Park Rd. N. Wallingford CT US 06492 06492

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HGL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K952031ULTRASOUND TRANSDUCER, MODEL US917Advanced Medical Systems, Inc.1995-07-18
K923335ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATIONAdvanced Medical Systems, Inc.1994-07-22
K924516OP3/VP4Huntleigh Technology, Inc.1993-06-28
K903348ULTRASONIC PULSED DOPPLER IMAGING SYSTEMAdvanced Technology Laboratories, Inc.1990-10-22
K900966EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBEHitachi Medical Corp. of America1990-09-12
K903316ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCERGe Medical Systems Information Technologies1990-08-22
K901142MER MULTIPLANE VAGINAL PROBE (MVP)Medical Equipment Resources1990-08-22
K900838TRANSVAGINAL TRANSDUCER ASSEMBLYPie Medical Equipment B.V.1990-05-23
K881263MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLERMultigon Industries, Inc.1990-01-05
K8956475.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCERAdvanced Technology Laboratories, Inc.1989-12-18
K8951235.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCERAdvanced Technology Laboratories, Inc.1989-11-13
K895026HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCERHewlett-Packard Co.1989-11-06
K894415DYMAX ENDOVAGINAL BIOPSY GUIDEDymax Corp1989-10-25
K892070GENERAL IVT NEEDLE GUIDE KIT, STERILEAmedic USA1989-09-05
K881405SIEMENS INTRAVAGINAL TRANSDUCERSiemens Medical Solutions USA, Inc.1988-08-02

Legacy Summary#

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FDA Review#

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