FORE-SIGHT ABSOLUTE TISSUE OXIMETER

Oximeter, Tissue Saturation

CAS MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Cas Medical Systems, Inc. with the FDA for Fore-sight Absolute Tissue Oximeter.

Pre-market Notification Details

Device IDK112820
510k NumberK112820
Device Name:FORE-SIGHT ABSOLUTE TISSUE OXIMETER
ClassificationOximeter, Tissue Saturation
Applicant CAS MEDICAL SYSTEMS, INC. 44 EAST INDUSTRIAL RD. Branford,  CT  06405
ContactRon Jeffrey
CorrespondentRon Jeffrey
CAS MEDICAL SYSTEMS, INC. 44 EAST INDUSTRIAL RD. Branford,  CT  06405
Product CodeMUD  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-28
Decision Date2012-01-26
Summary:summary

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