CRITICOOL— 510(k) K083662

Substantially Equivalent

Mtre Advanced Technology , Ltd.

FDA 510(k) clearance K083662 for CRITICOOL, Substantially Equivalent on 2009-03-26. Applicant: Mtre Advanced Technology , Ltd..

Clearance details

Applicant: Mtre Advanced Technology , Ltd.
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 2008-12-10
Decision date: 2009-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yavne, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWJ

product code DWJ

Death: 7
Injury: 679
Malfunction: 17,477
Total: 18,163

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.