Life Sensor Cardiac Monitor— 510(k) K191331

Name: FDA 510(k) clearance K191331
Creator: U.S. Food and Drug Administration
Published: 2019-06-12

Substantially Equivalent

Braveheart Wireless, Inc.

FDA 510(k) clearance K191331 for Life Sensor Cardiac Monitor, Substantially Equivalent on 2019-06-12. Applicant: Braveheart Wireless, Inc.. Device class: 2.

Clearance details

Applicant: Braveheart Wireless, Inc.
Product code: Code DRG
Device class: Class 2
Regulation: 21 CFR 870.2910
Advisory panel: Cardiovascular
Date received: 2019-05-16
Decision date: 2019-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nashua, NH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.