KLEAR-TEMP— 510(k) K926030

Substantially Equivalent

Cas Medical Systems, Inc.

FDA 510(k) clearance K926030 for KLEAR-TEMP, Substantially Equivalent on 1994-02-24. Applicant: Cas Medical Systems, Inc..

Clearance details

Applicant: Cas Medical Systems, Inc.
Product code: Code FMT
Advisory panel: General Hospital
Date received: 1992-12-01
Decision date: 1994-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branford, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMT

product code FMT

Death: 4
Malfunction: 3,074
Total: 3,078

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.