EDENTEC MULTI-CHANNEL RECORDER

Oximeter

EDENTEC CORP.

The following data is part of a premarket notification filed by Edentec Corp. with the FDA for Edentec Multi-channel Recorder.

Pre-market Notification Details

Device IDK873081
510k NumberK873081
Device Name:EDENTEC MULTI-CHANNEL RECORDER
ClassificationOximeter
Applicant EDENTEC CORP. 10252 VALLEY VIEW RD. Eden Prairie,  MN  55344
ContactEdward Schuck
CorrespondentEdward Schuck
EDENTEC CORP. 10252 VALLEY VIEW RD. Eden Prairie,  MN  55344
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-05
Decision Date1987-11-17

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