Data / Medical devices / United States / Applied Cardiac Systems, Inc.
Applied Cardiac Systems, Inc.: FDA-registered device maker in Lake Forest, CA, United States, 2 510(k) clearances
Applied Cardiac Systems, Inc. is registered with the FDA (registration 2024089) in Lake Forest, CA, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 24, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2024089
- Address
- 25651 Atlantic Ocean Dr Ste 14-15a, Lake Forest, CA, United States, 92630
- Owner or operator
- Applied Cardiac Systems, Inc. (2024089)
- Roles
- Manufacturer
- First device listed
- June 23, 2000
- Registered through
- 2026
- Brand names listed
- THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR, THE HOLTER REPORTER (TM)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Detector And Alarm, Arrhythmia | DSI | 2 | Manufacturer | accessdata.fda.gov |
| Electrocardiograph | DPS | 2 | Manufacturer | accessdata.fda.gov |
| Outpatient Cardiac Telemetry | QYX | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| August 24, 2011 | K103706 | THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR | QYX | Substantially Equivalent | Applied Cardiac Systems, Inc. | accessdata.fda.gov |
| March 11, 1986 | K860249 | THE HOLTER REPORTER (TM) | DPS | Substantially Equivalent | Applied Cardiac Systems | accessdata.fda.gov |
Compare with other makers
- All makers of Outpatient Cardiac Telemetry
- All makers of Detector And Alarm, Arrhythmia
- All makers of Electrocardiograph
Updated August 24, 2011. 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.