OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S

Oximeter, Tissue Saturation

SOMANETICS CORP.

The following data is part of a premarket notification filed by Somanetics Corp. with the FDA for Oxyalert Nirsensors, Accessories For Invos 5100c System, Models: Is-c And Is-s.

Pre-market Notification Details

Device IDK091224
510k NumberK091224
Device Name:OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S
ClassificationOximeter, Tissue Saturation
Applicant SOMANETICS CORP. 1653 EAST MAPLE RD. Troy,  MI  48083 -4208
ContactRonald A Widman
CorrespondentRonald A Widman
SOMANETICS CORP. 1653 EAST MAPLE RD. Troy,  MI  48083 -4208
Product CodeMUD  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-27
Decision Date2009-07-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521211138 K091224 000
10884521528062 K091224 000
10884521185883 K091224 000
10884521211186 K091224 000
10884521185869 K091224 000
10884521185876 K091224 000
10884521185890 K091224 000
10884521185906 K091224 000
10884521185913 K091224 000
20884521810379 K091224 000
20884521810362 K091224 000
10884521211117 K091224 000
10884521211179 K091224 000
10884521211193 K091224 000
10884521552623 K091224 000
10884521106086 K091224 000
10884521106222 K091224 000
20884521211121 K091224 000
10884521528055 K091224 000

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