JOM · Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Cardiovascular · 21 CFR 870.2780 · Class 2
Overview
| Product Code | JOM |
|---|---|
| Device Name | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Regulation | 21 CFR 870.2780 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 53)
Showing 20 most recent of 53 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K220527 | PADnet Xpress | Collaborative Care Diagnostics, LLC, D.B.A. Biomedix | Oct 20, 2022 | SESE |
| K213730 | MESI mTABLET TBI diagnostic system, MESI mTABLET TBI | Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. | Apr 21, 2022 | SESE |
| K200567 | ASI Plethysmogrpah Analyzer | Arterial Stiffness, Inc. | Feb 26, 2021 | SESE |
| K201046 | Automated ankle brachial pressure index measuring device, MESI mTABLET system | Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | Dec 11, 2020 | SESE |
| K191266 | VitalScan ANS | Medeia, Inc. | Jan 15, 2020 | SESE |
| K172655 | Automated ankle brachial pressure index measuring device | Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | Jan 11, 2018 | SESE |
| K173696 | TBL-ABI System | Ld Technology, LLC | Dec 19, 2017 | SESE |
| K143152 | TM-ABI system | Ld Technology, LLC | Jul 22, 2015 | SESE |
| K143094 | QuantaFlo | Semler Scientific, Inc. | Mar 5, 2015 | SESE |
| K123921 | BODYTRONIC 200 | Bauerfeind AG | Apr 26, 2013 | SESE |
| K121108 | DOPPLEX ABILITY | Huntleigh Healthcare | Jan 3, 2013 | SESE |
| K122281 | PADNET 2.0 | Biomedix, Inc. | Aug 29, 2012 | SESE |
| K110374 | MAX PULSE SYSTEM | Medicore Co., Ltd. | Jun 13, 2011 | SESE |
| K101983 | CRITICAL CARE ASSESSMENT | Critical Patient Care, Inc. | Sep 21, 2010 | SESE |
| K093192 | FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE | Advanced Vascular Dynamics | Feb 12, 2010 | SESE |
| K083735 | ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS | Medtechs, LLC | Feb 18, 2009 | SESE |
| K073323 | SA-3000P | Medicore Co., Ltd. | Nov 29, 2007 | SESE |
| K073146 | PADNET+ | Biomedix, Inc. | Nov 21, 2007 | SESE |
| K042616 | BIOMEDIX PADNET LAB | Biomedix, Inc. | Oct 12, 2004 | SESE |
| K023238 | MCPULSE | Meridian Co., Ltd. | Feb 19, 2003 | SESE |
Top Applicants
- D. E. Hokanson, Inc. — 5 clearances
- Biomedix, Inc. — 3 clearances
- Ld Technology, LLC — 2 clearances
- Life Sciences Manufacturing, Inc. — 2 clearances
- Medasonics, Inc. — 2 clearances
