Product code JOM
- Device name
- Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.2780
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220527 | PADnet Xpress | Collaborative Care Diagnostics, LLC, D.B.A. Biomedix | 2022-10-20 |
| K213730 | MESI mTABLET TBI diagnostic system, MESI mTABLET TBI | Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. | 2022-04-21 |
| K200567 | ASI Plethysmogrpah Analyzer | Arterial Stiffness, Inc. | 2021-02-26 |
| K201046 | Automated ankle brachial pressure index measuring device, MESI mTABLET system | Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | 2020-12-11 |
| K191266 | VitalScan ANS | Medeia, Inc. | 2020-01-15 |
| K172655 | Automated ankle brachial pressure index measuring device | Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | 2018-01-11 |
| K173696 | TBL-ABI System | Ld Technology, LLC | 2017-12-19 |
| K143152 | TM-ABI system | Ld Technology, LLC | 2015-07-22 |
| K143094 | QuantaFlo | Semler Scientific, Inc. | 2015-03-05 |
| K123921 | BODYTRONIC 200 | Bauerfeind AG | 2013-04-26 |
| K121108 | DOPPLEX ABILITY | Huntleigh Healthcare | 2013-01-03 |
| K122281 | PADNET 2.0 | Biomedix, Inc. | 2012-08-29 |
| K110374 | MAX PULSE SYSTEM | Medicore Co., Ltd. | 2011-06-13 |
| K101983 | CRITICAL CARE ASSESSMENT | Critical Patient Care, Inc. | 2010-09-21 |
| K093192 | FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE | Advanced Vascular Dynamics | 2010-02-12 |
| K083735 | ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS | Medtechs, LLC | 2009-02-18 |
| K073323 | SA-3000P | Medicore Co., Ltd. | 2007-11-29 |
| K073146 | PADNET+ | Biomedix, Inc. | 2007-11-21 |
| K042616 | BIOMEDIX PADNET LAB | Biomedix, Inc. | 2004-10-12 |
| K023238 | MCPULSE | Meridian Co., Ltd. | 2003-02-19 |
| K023707 | A16 BLOOD FLOW MEASUREMENT SYSTEM | D. E. Hokanson, Inc. | 2003-02-12 |
| K022047 | PHLEBOTEST 2000 | Osborn Medical Corp. | 2002-11-04 |
| K990123 | PVR-100/VASOGRAM | Vasocor, Inc. | 1999-04-12 |
| K983900 | VENOMETER | Advanced Medical Technology , Ltd. | 1999-01-29 |
| K982707 | EC6 PLETHYSMOGRAPH | D. E. Hokanson, Inc. | 1998-08-26 |
| K973659 | VASOCOR PVR 100 | Vasocor, Inc. | 1997-12-17 |
| K944395 | ELCAT D-PPG, PLETHYSMOGRAPH DEVICE | Dermatology Assoc. | 1995-05-10 |
| K905114 | A.P.GRAPH III(TM) CARDIOVASCULAR ANALYZER | Research Consultants, Inc. | 1991-05-07 |
| K896500 | CWD/PPG MODULE | Life Sciences Manufacturing, Inc. | 1990-07-18 |
| K884624 | MVL/MODULAB WITH PVR MODULE | Life Sciences Manufacturing, Inc. | 1989-02-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00862467000333 | PADnet Xpress | Collaborative Care Diagnostics, LLC | 2026-02-04 |
| 08690020003031 | VitalScan HRV | Medeia, Inc. | 2025-02-05 |
| 08690020003017 | VitalScan ANS | Medeia, Inc. | 2025-02-05 |
| B322G0011 | ANS1 Software | LD TECHNOLOGY, LLC | 2024-03-05 |
| B322H0011 | LD-EKG | LD TECHNOLOGY, LLC | 2024-03-05 |
| 05051968035370 | DOPPLEX | HUNTLEIGH HEALTHCARE LIMITED | 2022-10-10 |
| 03830059851523 | MESI mTABLET TBI | MESI d.o.o. | 2022-04-25 |
| 03830059851141 | MESI mTABLET ABI | MESI d.o.o. | 2021-07-09 |
| 03830059850366 | MESI ABPI MD | MESI d.o.o. | 2021-07-09 |
| 00884838093195 | Avalon Ultrasound Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 00884838093225 | Avalon Toco+ Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 00884838093218 | Avalon Toco MP Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 00884838093201 | Avalon ECG/IUP Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 00884838093188 | Avalon Toco+ MP Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 00191237000014 | SA-3000P | Medicore Co., Ltd. | 2019-04-10 |
| 10191237000011 | SA-3000P | Medicore Co., Ltd. | 2019-04-10 |
| 00191237000038 | Max Pulse | Medicore Co., Ltd. | 2019-03-05 |
| 40191237000036 | Max Pulse | Medicore Co., Ltd. | 2019-03-05 |
| B322C0011 | TBL-ABI | LD TECHNOLOGY, LLC | 2019-01-16 |
| 04051526903616 | MEDI | MEDI MANUFACTURING, INC. | 2018-11-20 |
| 04051526849631 | MEDI | MEDI MANUFACTURING, INC. | 2018-11-20 |
| 04051526846302 | MEDI | MEDI MANUFACTURING, INC. | 2018-11-20 |
| 04051526846463 | MEDI | MEDI MANUFACTURING, INC. | 2018-11-20 |
| 00817065021204 | Hokanson | D.E.HOKANSON, INC. | 2016-09-22 |
| 00817065021594 | Hokanson | D.E.HOKANSON, INC. | 2016-09-22 |
| 00817065021198 | Hokanson | D.E.HOKANSON, INC. | 2016-09-22 |
| 05051968013941 | DOPPLEX | HUNTLEIGH HEALTHCARE LIMITED | 2016-09-19 |
| 05051968030337 | DOPPLEX | HUNTLEIGH HEALTHCARE LIMITED | 2016-09-12 |
| 05051968030344 | DOPPLEX | HUNTLEIGH HEALTHCARE LIMITED | 2016-09-12 |
| 05051968030030 | DOPPLEX | HUNTLEIGH HEALTHCARE LIMITED | 2016-08-22 |