ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10— 510(k) K102206

Substantially Equivalent

Mortara Instrument, Inc.

FDA 510(k) clearance K102206 for ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10, Substantially Equivalent on 2011-02-18. Applicant: Mortara Instrument, Inc..

Clearance details

Applicant: Mortara Instrument, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2010-08-05
Decision date: 2011-02-18
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Milwaukee, WI, US

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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.