K122763

Substantially Equivalent

PHYSIOLOGICAL DATA PROCESSOR

Applicant: Zephyr Technology Corporation
Product code: DRG
Advisory panel: Cardiovascular
Date received: 2012-09-10
Decision date: 2013-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, 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.