Data / Medical devices / Electrocardiograph, Ambulatory, With Analysis Algorithm / United States
FDA-registered makers of Electrocardiograph, Ambulatory, With Analysis Algorithm in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make Electrocardiograph, Ambulatory, With Analysis Algorithm (product code MLO). 4 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Electrocardiograph, Ambulatory, With Analysis Algorithm
- Product code
- MLO
- Country
- United States
Makers of Electrocardiograph, Ambulatory, With Analysis Algorithm in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Welch Allyn, Inc. | Skaneateles Falls, NY, United States | Specification developer | 2 | September 26, 2005 | 0 | 0 | 0 | api.fda.gov |
| Global Instrumentation, LLC | E Syracuse, NY, United States | Manufacturer | 1 | September 26, 2005 | 0 | 0 | 0 | api.fda.gov |
| Philips North America LLC | Andover, MA, United States | Specification developer | 1 | September 28, 2001 | 0 | 0 | 0 | api.fda.gov |
| VivaQuant, Inc | Arden Hills, MN, United States | Manufacturer | 1 | September 2, 2020 | 0 | 0 | 0 | api.fda.gov |
| Clearpath Medical, LLC | Tustin, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medicomp, Inc. | Melbourne, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neurotronics, LLC | Alachua, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Murrysville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Export, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.