FDA 510(k) Applications for Medical Device Product Code "JOM"
(Plethysmograph, Photoelectric, Pneumatic Or Hydraulic)

FDA 510(k) Number Applicant Device Name Decision Date
K983900 ADVANCED MEDICAL TECHNOLOGY LTD. VENOMETER 01/29/1999
K093192 ADVANCED VASCULAR DYNAMICS FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE 02/12/2010
K200567 Arterial Stiffness Inc. ASI Plethysmogrpah Analyzer 02/26/2021
K123921 BAUERFEIND AG BODYTRONIC 200 04/26/2013
K042616 BIOMEDIX, INC. BIOMEDIX PADNET LAB 10/12/2004
K122281 BIOMEDIX, INC. PADNET 2.0 08/29/2012
K073146 BIOMEDIX, INC. PADNET+ 11/21/2007
K220527 Collaborative Care Diagnostics LLC, d.b.a. Biomedix PADnet Xpress 10/20/2022
K101983 CRITICAL PATIENT CARE, INC. CRITICAL CARE ASSESSMENT 09/21/2010
K023707 D. E. HOKANSON, INC. A16 BLOOD FLOW MEASUREMENT SYSTEM 02/12/2003
K982707 D. E. HOKANSON, INC. EC6 PLETHYSMOGRAPH 08/26/1998
K121108 HUNTLEIGH HEALTHCARE DOPPLEX ABILITY 01/03/2013
K173696 LD Technology LLC TBL-ABI System 12/19/2017
K143152 LD TECHNOLOGY LLC TM-ABI system 07/22/2015
K191266 Medeia, Inc. VitalScan ANS 01/15/2020
K110374 MEDICORE CO., LTD. MAX PULSE SYSTEM 06/13/2011
K073323 MEDICORE CO., LTD. SA-3000P 11/29/2007
K083735 MEDTECHS, LLC ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS 02/18/2009
K023238 MERIDIAN CO., LTD. MCPULSE 02/19/2003
K172655 Mesi D.O.O.; Mesi, Development of medical devices, Ltd. Automated ankle brachial pressure index measuring device 01/11/2018
K201046 Mesi D.O.O.; Mesi, Development of medical devices, Ltd. Automated ankle brachial pressure index measuring device, MESI mTABLET system 12/11/2020
K213730 Mesi, Development of Medical Devices, Ltd.; Mesi d.o.o. MESI mTABLET TBI diagnostic system, MESI mTABLET TBI 04/21/2022
K022047 OSBORN MEDICAL CORP. PHLEBOTEST 2000 11/04/2002
K143094 SEMLER SCIENTIFIC, INC. QuantaFlo 03/05/2015
K990123 VASOCOR, INC. PVR-100/VASOGRAM 04/12/1999
K973659 VASOCOR, INC. VASOCOR PVR 100 12/17/1997


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