Carnation Ambulatory Monitor— 510(k) K191471

Substantially Equivalent

Bardy Diagnostics, Inc.

FDA 510(k) clearance K191471 for Carnation Ambulatory Monitor, Substantially Equivalent on 2019-08-30. Applicant: Bardy Diagnostics, Inc..

Clearance details

Applicant: Bardy Diagnostics, Inc.
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 2019-06-03
Decision date: 2019-08-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.