510(k) K033048— CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS

Substantially Equivalent

Cas Medical Systems, Inc.

Clearance details

Applicant: Cas Medical Systems, Inc.
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2003-09-29
Decision date: 2004-06-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Branford, CT, US

Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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.