MEDILOG DARWIN HOLTER ANALYSIS— 510(k) K053369

Substantially Equivalent

Huntleigh Healthcare

FDA 510(k) clearance K053369 for MEDILOG DARWIN HOLTER ANALYSIS, Substantially Equivalent on 2005-12-22. Applicant: Huntleigh Healthcare.

Clearance details

Applicant: Huntleigh Healthcare
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2005-12-05
Decision date: 2005-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Surrey, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.