K233110
- 510(k) number
- K233110
- Device name
- Carnation Ambulatory Monitor
- Applicant
- Bardy Diagnostics, Inc. WA · US
- Product code
- DSH — Recorder, Magnetic Tape, Medical
- Decision date
- 2023-11-22
- Date received
- 2023-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K233110
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.