SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)

Oximeter

SOMANETICS CORP.

The following data is part of a premarket notification filed by Somanetics Corp. with the FDA for Somanetics Invos 3100a Cerebral Oximeter (invos).

Pre-market Notification Details

Device IDK960614
510k NumberK960614
Device Name:SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)
ClassificationOximeter
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 CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-02-13
Decision Date1996-06-05
Summary:summary

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