FORE-SIGHT ELITE 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 Elite Absolute Tissue Oximeter.

Pre-market Notification Details

Device IDK123700
510k NumberK123700
Device Name:FORE-SIGHT ELITE 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 Received2012-12-03
Decision Date2013-04-11
Summary:summary

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