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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