HEALTHINTERLINK BEACON— 510(k) K133252

Substantially Equivalent

Healthinterlink, LLC

FDA 510(k) clearance K133252 for HEALTHINTERLINK BEACON, Substantially Equivalent on 2014-03-14. Applicant: Healthinterlink, LLC.

Clearance details

Applicant: Healthinterlink, LLC
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 2013-10-22
Decision date: 2014-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

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.