EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS.

Oximeter

EDENTEC CORP.

The following data is part of a premarket notification filed by Edentec Corp. with the FDA for Edentec Model 2000w Option S Cardio-resp. Process..

Pre-market Notification Details

Device IDK884614
510k NumberK884614
Device Name:EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS.
ClassificationOximeter
Applicant EDENTEC CORP. 10252 VALLEY VIEW RD. Eden Prairie,  MN  55344
ContactEd Schuck
CorrespondentEd 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 Received1988-11-04
Decision Date1989-02-01

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