Bardy Diagnostics, Inc.
Bellevue, WA, US
BARDY DIAGNOSTICS, INC. appears in FDA device records in Bellevue, WA. FDA records list 7 510(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 7 510(k) clearances for Bardy Diagnostics, Inc. between 2014 and 2023. The busiest year on record is 2019, with 3. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2019 | 3 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233110 | Carnation Ambulatory Monitor | DSH | Substantially Equivalent | |
| K210036 | Carnation Ambulatory Monitor (CAM) | DSH | Substantially Equivalent | |
| K200870 | Carnation Ambulatory Monitor | DSH | Substantially Equivalent | |
| K192556 | Carnation Ambulatory Monitor | DSH | Substantially Equivalent | |
| K191471 | Carnation Ambulatory Monitor | DSH | Substantially Equivalent | |
| K191000 | Carnation Ambulatory Monitor | DSH | Substantially Equivalent | |
| K143067 | Carnation Ambulatory Monitor | DSH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014226707 | 3014226707 | BARDY DIAGNOSTICS, INC. | 220 120th Avenue NE, Suite 100, 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