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510(k) K895026

Device
HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER
Applicant
HEWLETT-PACKARD CO.
510(k) number
K895026
Product code
HGL  
Decision
Substantially Equivalent (SESE)
Decision date
1989-11-06
Date received
1989-08-08
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
CHARLES R BURR
Address
3000 Minuteman Rd. Andover MA US 01810 01810

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
K895449ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEMGe Medical Systems Information Technologies1990-03-05
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
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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