JOM — Plethysmograph, Photoelectric, Pneumatic Or Hydraulic Class II

FDA Device Classification

Classification Details

Product Code
JOM
Device Class
Class II
Regulation Number
870.2780
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K220527collaborative care diagnostics, llc, d.b.a. biomedixPADnet XpressOctober 20, 2022
K213730mesi, development of medical devices, ltd.; mesiMESI mTABLET TBI diagnostic system, MESI mTABLET TBIApril 21, 2022
K200567arterial stiffnessASI Plethysmogrpah AnalyzerFebruary 26, 2021
K201046mesi d.o.o.; mesi, development of medical devicesAutomated ankle brachial pressure index measuring device, MESI mTABLET systemDecember 11, 2020
K191266medeiaVitalScan ANSJanuary 15, 2020
K172655mesi d.o.o.; mesi, development of medical devicesAutomated ankle brachial pressure index measuring deviceJanuary 11, 2018
K173696ld technologyTBL-ABI SystemDecember 19, 2017
K143152ld technologyTM-ABI systemJuly 22, 2015
K143094semler scientificQuantaFloMarch 5, 2015
K123921bauerfeindBODYTRONIC 200April 26, 2013
K121108huntleigh healthcareDOPPLEX ABILITYJanuary 3, 2013
K122281biomedixPADNET 2.0August 29, 2012
K110374medicore coMAX PULSE SYSTEMJune 13, 2011
K101983critical patient careCRITICAL CARE ASSESSMENTSeptember 21, 2010
K093192advanced vascular dynamicsFLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICEFebruary 12, 2010
K083735medtechsANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUSFebruary 18, 2009
K073323medicore coSA-3000PNovember 29, 2007
K073146biomedixPADNET+November 21, 2007
K042616biomedixBIOMEDIX PADNET LABOctober 12, 2004
K023238meridian coMCPULSEFebruary 19, 2003