This page includes the latest FDA filings for Cardiac Insight Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3010342616 |
| FEI Number | 3010342616 |
| Name | CARDIAC INSIGHT, INC. |
| Owner & Operator | Cardiac Insight, Inc. |
| Contact Address | 2375 130th Ave NE Suite 101 Bellevue WA 98005 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 2375 130th Ave NE Suite 101 Bellevue, WA 98005 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
| CARDIAC INSIGHT, INC. | Cardea 20/20 ECG CS-2020-B | 2023-09-01 |
| CARDIAC INSIGHT, INC. | Stealth System S300 M300-5 | 2019-11-08 |
| CARDIAC INSIGHT, INC. | Cardea SOLO M300-5 | 2019-11-08 |
| CARDIAC INSIGHT, INC. | Cardea SOLO D300 | 2019-11-08 |
| CARDIAC INSIGHT, INC. | Cardea SOLO C300/D300 | 2019-11-08 |
| CARDIAC INSIGHT, INC. | Stealth System S300 C300/D300 | 2019-11-08 |
| CARDIAC INSIGHT, INC. | CardeaScreen CS-2020-A | 2019-08-06 |
Cardiac Insight, Inc. | Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software | 2017-03-24 |
CARDIAC INSIGHT, INC. | Stealth System S300 | 2017-03-24 |
CARDIAC INSIGHT, INC. | Cardea SOLO | 2017-03-24 |
CARDIAC INSIGHT, INC. | Stealth System S300 | 2017-03-24 |
CARDIAC INSIGHT, INC. | Cardea SOLO | 2017-03-24 |
CARDIAC INSIGHT, INC. | MedicECG | 2015-10-05 |
CARDIAC INSIGHT, INC. | CardeaScreen | 2015-10-05 |
CARDIAC INSIGHT, INC. | Cardea 20/20 ECG | 2015-10-05 |
CARDIAC INSIGHT, INC. | Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System | 2015-07-11 |
CARDIAC INSIGHT, INC. | Cardiac Insight Stealth(tm) Monitor | 2013-06-17 |
CARDIAC INSIGHT, INC. | STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE | 2013-05-29 |
| NCAGE Code | 54QP3 | CARDIAC INSIGHT, INC. |
| CAGE Code | 54QP3 | CARDIAC INSIGHT, INC. |
| S.A.M. Registration | 54QP3 [827419834] | CARDIAC INSIGHT, INC. |
| SEC | 0001509098 | CARDIAC INSIGHT, INC. of WASHINGTON |