510(k) K252984— Perin Health System (PHD80060-2)

Substantially Equivalent

Perin Health Devices, LLC

Clearance details

Applicant: Perin Health Devices, LLC
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 2025-09-18
Decision date: 2026-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oklahoma City, OK, US

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.