Data / Medical devices / United States / Icon LLC
Icon LLC: FDA-registered device maker in Rochester, NY, United States, 5 510(k) clearances
Icon LLC is registered with the FDA (registration 3014522540) in Rochester, NY, United States. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 24, 2020. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3014522540
- Address
- 957 Panorama Trail S. Suite 190, Rochester, NY, United States, 14625
- Owner or operator
- ICON LLC (10088441)
- Roles
- Repackager or relabeler
- First device listed
- July 24, 2023
- Registered through
- 2027
- Brand names listed
- ELI 150C, H12+ Holter, KardiaMobile, M12, ePatch
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrocardiograph | DPS | 2 | Repackager or relabeler | accessdata.fda.gov |
| Electrocardiograph Software For Over-The-Counter Use | QDA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Electrocardiograph, Ambulatory, With Analysis Algorithm | MLO | 2 | Repackager or relabeler | accessdata.fda.gov |
| Recorder, Magnetic Tape, Medical | DSH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 24, 2020 | K191406 | KardiaMobile, KardiaStation | DXH | Substantially Equivalent | AliveCor, Inc. | accessdata.fda.gov |
| January 4, 2018 | K171410 | ePatch | DSH | Substantially Equivalent | Braemar Manufacturing, LLC | accessdata.fda.gov |
| July 3, 2013 | K131573 | CP150 ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| September 26, 2005 | K051730 | MATRIX HOLTER SYSTEM, MODEL M12 | MLO | Substantially Equivalent | Global Instrumentation, LLC | accessdata.fda.gov |
| August 24, 2005 | K050896 | H12+ HOLTER RECORDER | DSH | Substantially Equivalent | Mortara Instrument, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Recorder, Magnetic Tape, Medical
- All makers of Electrocardiograph
- All makers of Electrocardiograph, Ambulatory, With Analysis Algorithm
- All makers of Transmitters And Receivers, Electrocardiograph, Telephone
- All makers of Electrocardiograph Software For Over-The-Counter Use
Updated January 24, 2020. 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.