CardioSTAT - CardioSTAT ECG Recorder 2D Test
2025-12-08
ICENTIA Inc
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014271754 | 3014271754 | ICENTIA Inc | 1 | N | 2026-01-01 | 2750 rue Einstein Quebec CA G1P 4R1 |
| 3030721635 | 3030721635 | ICENTIA LLC | 1 | Y | 2026-01-01 | 106 Main Street Burlington VT US 05401 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 293965 | 1001655434 | K223049 | CardioSTAT® ECG Test Solution | DSH | 2023-03-22 |
| 327061 | 1711662442 | K223049 | CardioSTAT® ECG Test Solution | DSH | 2023-03-22 |
| 293965 | 1354072844 | ||||
| 293965 | 1382876250 | ||||
| 293965 | 1584650889 |
Product Codes Associated With Registrations
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DSH | 2 | 2023-03-22 |
GUDID
CardioSTAT - CardioSTAT Installation Kit - ECG Recorder 2D Test.
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CardioSTAT - CardioSTAT Installation Kit - ECG Recorder 7D Test
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CardioSTAT - CardioSTAT Installation Kit - ECG Recorder 14D Test
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OFIX - OFIX adhesive disks
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EART - ECG Analysis and Reporting Tool.
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CardioSTAT - CardioSTAT ECG Recorder 7D Test.
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CardioSTAT - CardioSTAT ECG Recorder 14D test.
2024-03-26