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DSK — Computer, Blood-Pressure Class II

FDA Device Classification

Classification Details

Product Code
DSK
Device Class
Class II
Regulation Number
870.1110
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K231586endophys technologiesEndophys Blood Pressure Monitor model BPM-30November 3, 2023
K160945endophys holdingsEndophys Blood Pressure MonitorSeptember 26, 2016
K152582volcano corporationCORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter BoxDecember 3, 2015
K141615endophysENDOPHYS BLOOD PRESSURE MONITORJanuary 7, 2015
K080670atcor medicalMODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMApril 23, 2008
K070795atcor medical ptySPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAugust 31, 2007
K033738schillerMONITORING SYSTEM, MODEL ARGUS PB-2200August 24, 2004
K021517rozinn electronicsABP FOR WINDOWSJuly 24, 2002
K013943radi medical systemsRADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720December 18, 2001
K011865zoll medicalZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTIONJuly 31, 2001
K003122florence medicalSMARTFLOW, MODEL SFIP 2000May 14, 2001
K002742pwv medical pty, ltSPHYGMOCOR MX MODEL SCOR-MXMay 1, 2001
K002067radi medical systemsRADIANALYZER, MODEL 12710January 11, 2001
K983250magnetic resonance equipmentINVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITORDecember 12, 1999
K951226pace techVITALMAX 4000/MINIPACK 3100/3000November 21, 1996
K943457datex division instrumentariumAS/3 PRESSURE TEMPERATURE MODULE, M-PTJuly 27, 1994
K921388biochem internationalBIOCHEM 9100 MULTIGAS MONITOR IBP MODULEMay 26, 1993
K925899welch allynAMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01May 21, 1993
K914273a and d engineeringA&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITORFebruary 9, 1993
K912816s and w medico teknikPRESS 1 PRESS 2 9220 UPDATING OF THE MODULEApril 10, 1992