510(k) K100127— ELI 230 ELECTROCARDIOGRAPH

Substantially Equivalent

Mortara Instrument, Inc.

Clearance details

Applicant: Mortara Instrument, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2010-01-19
Decision date: 2010-04-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Milwaukee, WI, US

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.