510(k) K251221— Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)

Substantially Equivalent

Abbott

Clearance details

Applicant: Abbott
Product code: Code MXD
Advisory panel: Cardiovascular
Date received: 2025-04-21
Decision date: 2025-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sylmar, CA, US

Adverse events under product code MXD

product code MXD

Injury: 1,880
Malfunction: 9,487
Total: 11,367

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.