FDA Product Code
FDA Product Code JOM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2780
510(k) Clearances — 53 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K220527 | PADnet Xpress | Collaborative Care Diagnostics, LLC, D.B.A. Biomedix | 2022-10-20 | Special | PDF ↗ |
| K213730 | MESI mTABLET TBI diagnostic system, MESI mTABLET TBI | Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. | 2022-04-21 | Traditional | PDF ↗ |
| K200567 | ASI Plethysmogrpah Analyzer | Arterial Stiffness, Inc. | 2021-02-26 | Traditional | PDF ↗ |
| K201046 | Automated ankle brachial pressure index measuring device, MESI mTABLET system | Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | 2020-12-11 | Traditional | PDF ↗ |
| K191266 | VitalScan ANS | Medeia, Inc. | 2020-01-15 | Traditional | PDF ↗ |
| K172655 | Automated ankle brachial pressure index measuring device | Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | 2018-01-11 | Traditional | PDF ↗ |
| K173696 | TBL-ABI System | Ld Technology, LLC | 2017-12-19 | Special | PDF ↗ |
| K143152 | TM-ABI system | Ld Technology, LLC | 2015-07-22 | Traditional | PDF ↗ |
| K143094 | QuantaFlo | Semler Scientific, Inc. | 2015-03-05 | Traditional | PDF ↗ |
| K123921 | BODYTRONIC 200 | Bauerfeind AG | 2013-04-26 | Traditional | PDF ↗ |
| K121108 | DOPPLEX ABILITY | Huntleigh Healthcare | 2013-01-03 | Traditional | PDF ↗ |
| K122281 | PADNET 2.0 | Biomedix, Inc. | 2012-08-29 | Traditional | PDF ↗ |
| K110374 | MAX PULSE SYSTEM | Medicore Co., Ltd. | 2011-06-13 | Traditional | PDF ↗ |
| K101983 | CRITICAL CARE ASSESSMENT | Critical Patient Care, Inc. | 2010-09-21 | Traditional | PDF ↗ |
| K093192 | FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE | Advanced Vascular Dynamics | 2010-02-12 | Traditional | PDF ↗ |
| K083735 | ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS | Medtechs, LLC | 2009-02-18 | Traditional | PDF ↗ |
| K073323 | SA-3000P | Medicore Co., Ltd. | 2007-11-29 | Traditional | PDF ↗ |
| K073146 | PADNET+ | Biomedix, Inc. | 2007-11-21 | Special | PDF ↗ |
| K042616 | BIOMEDIX PADNET LAB | Biomedix, Inc. | 2004-10-12 | Traditional | PDF ↗ |
| K023238 | MCPULSE | Meridian Co., Ltd. | 2003-02-19 | Traditional | PDF ↗ |
| K023707 | A16 BLOOD FLOW MEASUREMENT SYSTEM | D. E. Hokanson, Inc. | 2003-02-12 | Special | PDF ↗ |
| K022047 | PHLEBOTEST 2000 | Osborn Medical Corp. | 2002-11-04 | Traditional | PDF ↗ |
| K990123 | PVR-100/VASOGRAM | Vasocor, Inc. | 1999-04-12 | Traditional | PDF ↗ |
| K983900 | VENOMETER | Advanced Medical Technology , Ltd. | 1999-01-29 | Abbreviated | PDF ↗ |
| K982707 | EC6 PLETHYSMOGRAPH | D. E. Hokanson, Inc. | 1998-08-26 | Special | PDF ↗ |
| K973659 | VASOCOR PVR 100 | Vasocor, Inc. | 1997-12-17 | Traditional | PDF ↗ |
| K944395 | ELCAT D-PPG, PLETHYSMOGRAPH DEVICE | Dermatology Assoc. | 1995-05-10 | Traditional | PDF ↗ |
| K905114 | A.P.GRAPH III(TM) CARDIOVASCULAR ANALYZER | Research Consultants, Inc. | 1991-05-07 | Traditional | PDF ↗ |
| K896500 | CWD/PPG MODULE | Life Sciences Manufacturing, Inc. | 1990-07-18 | Traditional | PDF ↗ |
| K884624 | MVL/MODULAB WITH PVR MODULE | Life Sciences Manufacturing, Inc. | 1989-02-01 | Traditional | PDF ↗ |
| K884451 | DOPCORD PPG | Huntleigh Technology, Inc. | 1989-01-12 | Traditional | PDF ↗ |
| K882547 | VARITEST | Eureka AB | 1988-11-03 | Traditional | PDF ↗ |
| K883908 | 3D VASCULAR RECORDER | D. E. Hokanson, Inc. | 1988-10-28 | Traditional | PDF ↗ |
| K875118 | PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 101 | Bloodflow Laboratory, Inc. | 1988-05-16 | Traditional | PDF ↗ |
| K872517 | TL 400 TOTALAB VASCULAR DIAGNOSTIC SYSTEM | D. E. Hokanson, Inc. | 1987-10-01 | Traditional | PDF ↗ |
| K863702 | PULSE CUFF RECORDER MODEL PCR100 | Imex Medical Systems, Inc. | 1987-06-12 | Traditional | PDF ↗ |
| K863803 | VASOPULSE(TM)/MODEL 5000 | Sonicaid, Inc. | 1987-05-06 | Traditional | PDF ↗ |
| K853331 | OSM-1 OXYGEN SATURATION MONITOR | Criticare Systems, Inc. | 1986-01-14 | Traditional | PDF ↗ |
| K853124 | NOVAMETRIX PULSE OXIMETER, MODEL 500 | Novametrix Medical Systems, Inc. | 1985-11-06 | Traditional | PDF ↗ |
| K851128 | DIGITMATIC DM2 | Medimatic | 1985-07-19 | Traditional | PDF ↗ |
| K833561 | LIGHT REFLECTION RHEOGRAPHY | Instru-Med, Inc. | 1985-01-08 | Traditional | PDF ↗ |
| K832374 | PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH | Sonicaid, Inc. | 1983-12-01 | Traditional | PDF ↗ |
| K832528 | MGI STRENGTH/FITNESS SYS-MODEL #PU-101 | Mgi Strength/Fitness Systems, Inc. | 1983-10-20 | Traditional | PDF ↗ |
| K831955 | HR 100T | Thought Technology , Ltd. | 1983-08-11 | Traditional | PDF ↗ |
| K812609 | VASCULAB #VSC21 | Medasonics, Inc. | 1981-10-02 | Traditional | PDF ↗ |
| K801291 | EC-4 PLETHYSMOGRAPH | D. E. Hokanson, Inc. | 1980-07-08 | Traditional | PDF ↗ |
| K791927 | HEART RATE COMPUTER STRIP CHART | Stanford Assoc., Inc. | 1979-11-13 | Traditional | PDF ↗ |
| K790999 | APOLLO HEART RATE INDICATOR | Apollo Products, Inc. | 1979-06-22 | Traditional | PDF ↗ |
| K790450 | NOVATEC PRM | Novatec, Inc. | 1979-04-06 | Traditional | PDF ↗ |
| K782132 | PLETHYSMOGRAPH, STRAIN GAUGE | Medasonics, Inc. | 1979-02-26 | Traditional | PDF ↗ |
| K780761 | ELECTRO-PLETHYSMOGRAPH | Biotecx Laboratories, Inc. | 1978-06-30 | Traditional | PDF ↗ |
| K770332 | AMPLIFIER, PHOTOPULSE, MODEL PA13 | Medsonics | 1977-02-24 | Traditional | PDF ↗ |
| K760504 | PLETHYSMOGRAPH (MDI SYSTEM II) | Marketing Development Intl. | 1976-08-26 | Traditional | PDF ↗ |
Product code JOM · Class II · Cardiovascular. Data: openFDA.