Cardiac Insight, Inc.
Bellevue, WA, US
CARDIAC INSIGHT, INC. appears in FDA device records in Bellevue, WA. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Cardiac Insight, Inc. between 2013 and 2017. The busiest year on record is 2013, with 1. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K162503 | Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software | DSH | Substantially Equivalent | |
| K142468 | Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System | DSH | Substantially Equivalent | |
| K130288 | STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE | DSH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010342616 | 3010342616 | CARDIAC INSIGHT, INC. | 2375 130th Ave NE, Bellevue, WA 98005 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain