Data / Medical devices / United States / Bardy Diagnostics, Inc.
Bardy Diagnostics, Inc.: FDA-registered device maker in Bellevue, WA, United States, 1 510(k) clearance
Bardy Diagnostics, Inc. is registered with the FDA (registration 3014226707) in Bellevue, WA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 22, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014226707
- Address
- 220 120th Avenue NE, Suite 100, Bellevue, WA, United States, 98005
- Owner or operator
- BAXTER HEALTHCARE CORPORATION (1417572)
- Roles
- Specification developer
- First device listed
- April 15, 2014
- Registered through
- 2027
- Brand names listed
- Adhesive Ring, CAM System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Recorder, Magnetic Tape, Medical | DSH | 2 | Specification developer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | 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 |
|---|---|---|---|---|---|---|
| November 22, 2023 | K233110 | Carnation Ambulatory Monitor | DSH | Substantially Equivalent | Bardy Diagnostics, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 22, 2023. 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.