Data / Medical devices / United States / Premier Heart, LLC
Premier Heart, LLC: FDA-registered device maker in Port Washington, NY, United States, 1 510(k) clearance
Premier Heart, LLC is registered with the FDA (registration 2438852) in Port Washington, NY, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 21, 2000. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2438852
- FEI number
- 3003289183
- Address
- 110 Main St Suites 201-88, Port Washington, NY, United States, 11050
- Owner or operator
- Premier Heart, LLC (10023470)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 26, 2007
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| March 21, 2000 | K992703 | CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800 | DQK | Substantially Equivalent | Premier Heart, LLC | accessdata.fda.gov |
Compare with other makers
Updated March 21, 2000. 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.