CORA (Coagulation Resonance Analysis) System— 510(k) K150041

Substantially Equivalent

Coramed Technologies, LLC

FDA 510(k) clearance K150041 for CORA (Coagulation Resonance Analysis) System, Substantially Equivalent on 2015-06-26. Applicant: Coramed Technologies, LLC.

Clearance details

Applicant: Coramed Technologies, LLC
Product code: Code JPA
Advisory panel: Hematology
Date received: 2015-01-09
Decision date: 2015-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niles, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JPA

product code JPA

Death: 6
Total: 6

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.