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510(k) K900002

Device
DOPPLER OPTION FOR PLATINUM
Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
510(k) number
K900002
Product code
DXK  
Decision
Substantially Equivalent (SESE)
Decision date
1990-04-02
Date received
1990-01-02
Regulation
870.2330
Classification name
Echocardiograph
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
GLADYS D MAY
Address
2722 S. Fairview St. Santa Ana CA US 92704 92704

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DXK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K181042Ultra ICE Plus – PI 9 MHz Peripheral Imaging CatheterBoston Scientific Corporation2018-05-17
K160173Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)Boston Scientific Corporation2016-02-26
K031148IN-VISION IMAGING SYSTEMJomed, Inc.2003-05-28
K9348879750 ATHENA ETHERNET OPTIONS & W Medico Teknik A/S1994-01-14
K913209ACCESSORY TO GENESIS III (GCFM)Biosound, Inc.1992-05-15
K911384CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600Endosonics Corp.1991-06-25
K904832MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYSTHewlett-Packard Co.1991-04-22
K904978SOFTWARE PROGRAM USED W/PRISM PRODUCTSPrism Imaging, Inc.1991-02-25
K904977CINE/VIEW PLUS - CARDIOLOGY WORKSTATIONPrism Imaging, Inc.1991-02-25
K904976CINE'VIEW - STRESS ECHO & IMAGE REVIEWPrism Imaging, Inc.1991-02-25
K904975VISTA VIEWING STATIONPrism Imaging, Inc.1991-02-25
K910029PATIENT CARE MANAGEMENT SYSTEM MODIFICATIONSpacelabs, Inc.1991-01-31
K903839INTERSPEC APOGEEInterspec, Inc.1990-11-16
K903710WASHINGTON CARDIAC MONITORWashington Biolab, Inc.1990-11-09
K901592MODEL MD-5 DOPPLERD. E. Hokanson, Inc.1990-10-22

Legacy Summary#

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FDA Review#

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