COMFORT EZ— 510(k) K121632

Substantially Equivalent

Simple Diagnostics, Inc.

FDA 510(k) clearance K121632 for COMFORT EZ, Substantially Equivalent on 2012-08-10. Applicant: Simple Diagnostics, Inc..

Clearance details

Applicant: Simple Diagnostics, Inc.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 2012-06-04
Decision date: 2012-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

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Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.