FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030— 510(k) K094030

Substantially Equivalent

Cas Medical Systems, Inc.

FDA 510(k) clearance K094030 for FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030, Substantially Equivalent on 2010-12-23. Applicant: Cas Medical Systems, Inc..

Clearance details

Applicant: Cas Medical Systems, Inc.
Product code: Code MUD
Advisory panel: Cardiovascular
Date received: 2009-12-30
Decision date: 2010-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branford, CT, US

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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.