FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER— 510(k) K133879

Substantially Equivalent

Cas Medical Systems, Inc.

FDA 510(k) clearance K133879 for FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER, Substantially Equivalent on 2014-04-29. Applicant: Cas Medical Systems, Inc..

Clearance details

Applicant: Cas Medical Systems, Inc.
Product code: Code MUD
Advisory panel: Cardiovascular
Date received: 2013-12-20
Decision date: 2014-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branford, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MUD

product code MUD

Malfunction: 467
Total: 467

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.