JOM — Plethysmograph, Photoelectric, Pneumatic Or Hydraulic Class II
FDA product code JOM covers "Plethysmograph, Photoelectric, Pneumatic Or Hydraulic", a Class II medical device regulated under 21 CFR 870.2780. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JOM
- Device Class
- Class II
- Regulation Number
- 870.2780
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K220527 | collaborative care diagnostics, llc, d.b.a. biomedix | PADnet Xpress | October 20, 2022 |
| K213730 | mesi, development of medical devices, ltd.; mesi | MESI mTABLET TBI diagnostic system, MESI mTABLET TBI | April 21, 2022 |
| K200567 | arterial stiffness | ASI Plethysmogrpah Analyzer | February 26, 2021 |
| K201046 | mesi d.o.o.; mesi, development of medical devices | Automated ankle brachial pressure index measuring device, MESI mTABLET system | December 11, 2020 |
| K191266 | medeia | VitalScan ANS | January 15, 2020 |
| K172655 | mesi d.o.o.; mesi, development of medical devices | Automated ankle brachial pressure index measuring device | January 11, 2018 |
| K173696 | ld technology | TBL-ABI System | December 19, 2017 |
| K143152 | ld technology | TM-ABI system | July 22, 2015 |
| K143094 | semler scientific | QuantaFlo | March 5, 2015 |
| K123921 | bauerfeind | BODYTRONIC 200 | April 26, 2013 |
| K121108 | huntleigh healthcare | DOPPLEX ABILITY | January 3, 2013 |
| K122281 | biomedix | PADNET 2.0 | August 29, 2012 |
| K110374 | medicore co | MAX PULSE SYSTEM | June 13, 2011 |
| K101983 | critical patient care | CRITICAL CARE ASSESSMENT | September 21, 2010 |
| K093192 | advanced vascular dynamics | FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE | February 12, 2010 |
| K083735 | medtechs | ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS | February 18, 2009 |
| K073323 | medicore co | SA-3000P | November 29, 2007 |
| K073146 | biomedix | PADNET+ | November 21, 2007 |
| K042616 | biomedix | BIOMEDIX PADNET LAB | October 12, 2004 |
| K023238 | meridian co | MCPULSE | February 19, 2003 |