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510(k) K070795

Device
SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
Applicant
ATCOR MEDICAL PTY. LTD
510(k) number
K070795
Product code
DSK  
Decision
Substantially Equivalent (SESE)
Decision date
2007-08-31
Date received
2007-03-22
Regulation
870.1110
Classification name
Computer, Blood-pressure
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
EVAN P PHELPS
Address
1400 16th St., NW Suite 400 Washington, D.C. DC US 20036 20036

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DSK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLC2023-11-03
K160945Endophys Blood Pressure MonitorEndophys Holdings, LLC2016-09-26
K152582CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter BoxVolcano Corporation2015-12-03
K141615ENDOPHYS BLOOD PRESSURE MONITOREndophys, Inc.2015-01-07
K080670MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor Medical2008-04-23
K033738MONITORING SYSTEM, MODEL ARGUS PB-2200Schiller AG2004-08-24
K021517ABP FOR WINDOWSRozinn Electronics, Inc.2002-07-24
K013943RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720Radi Medical Systems AB2001-12-18
K011865ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTIONZoll Medical Corp2001-07-31
K003122SMARTFLOW, MODEL SFIP 2000Florence Medical , Ltd.2001-05-14
K002742SPHYGMOCOR MX MODEL SCOR-MXPwv Medical Pty, Lt.2001-05-01
K002067RADIANALYZER, MODEL 12710Radi Medical Systems AB2001-01-11
K983250INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITORMagnetic Resonance Equipment Corp.1999-12-12
K951226VITALMAX 4000/MINIPACK 3100/3000Pace Tech, Inc.1996-11-21
K943457AS/3 PRESSURE TEMPERATURE MODULE, M-PTDatex Division Instrumentarium Corp.1994-07-27

Legacy Summary#

summary

FDA Review#

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