FORE-SIGHT ABSOLUTE TISSUE OXIMETER— 510(k) K112820

Name: FDA 510(k) clearance K112820
Creator: U.S. Food and Drug Administration
Published: 2012-01-26

Substantially Equivalent

Cas Medical Systems, Inc.

FDA 510(k) clearance K112820 for FORE-SIGHT ABSOLUTE TISSUE OXIMETER, Substantially Equivalent on 2012-01-26. Applicant: Cas Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Cas Medical Systems, Inc.
Product code: Code MUD
Device class: Class 2
Regulation: 21 CFR 870.2700
Advisory panel: Cardiovascular
Date received: 2011-09-28
Decision date: 2012-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branford, CT, US

Download summary PDF View on FDA.gov ↗

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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.