Data / Medical devices / United States / Cardiac Insight, Inc.
Cardiac Insight, Inc.: FDA-registered device maker in Bellevue, WA, United States, 2 510(k) clearances
Cardiac Insight, Inc. is registered with the FDA (registration 3010342616) in Bellevue, WA, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 24, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010342616
- Address
- 2375 130th Ave NE Suite 101, Bellevue, WA, United States, 98005
- Owner or operator
- Cardiac Insight, Inc. (10044470)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- October 5, 2015
- Registered through
- 2026
- Brand names listed
- Cardea 20/20 ECG, Cardea SOLO, CardeaScreen, MedicECG, Stealth System S300
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Electrocardiograph | DPS | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Recorder, Magnetic Tape, Medical | DSH | 2 | Complaint file establishment, 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 24, 2017 | K162503 | Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software | DSH | Substantially Equivalent | Cardiac Insight, Inc. | accessdata.fda.gov |
| February 5, 2013 | K123217 | CARDEASCREEN | DPS | Substantially Equivalent | Cardea Associates, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrocardiograph
- All makers of Recorder, Magnetic Tape, Medical
- All makers of Computer, Diagnostic, Programmable
Updated March 24, 2017. 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.