Tempus IC2— 510(k) K152124

Substantially Equivalent

Remote Diagnostics Technologies, Ltd.

FDA 510(k) clearance K152124 for Tempus IC2, Substantially Equivalent on 2015-10-28. Applicant: Remote Diagnostics Technologies, Ltd..

Clearance details

Applicant: Remote Diagnostics Technologies, Ltd.
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2015-07-31
Decision date: 2015-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basingstoke, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.