740 SELECT— 510(k) K150620

Substantially Equivalent

Cas Medical Systems, Inc.

FDA 510(k) clearance K150620 for 740 SELECT, Substantially Equivalent on 2015-05-08. Applicant: Cas Medical Systems, Inc..

Clearance details

Applicant: Cas Medical Systems, Inc.
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2015-03-10
Decision date: 2015-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branford, CT, US

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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.