ACCUTRAX, MODEL EPF840

Meter, Peak Flow, Spirometry

KORR MEDICAL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Korr Medical Technologies, Inc. with the FDA for Accutrax, Model Epf840.

Pre-market Notification Details

Device IDK982995
510k NumberK982995
Device Name:ACCUTRAX, MODEL EPF840
ClassificationMeter, Peak Flow, Spirometry
Applicant KORR MEDICAL TECHNOLOGIES, INC. 3090 EAST 3300 SOUIH #3B Salt Lake City,  UT  84109 -2106
ContactScott Kofoed
CorrespondentScott Kofoed
KORR MEDICAL TECHNOLOGIES, INC. 3090 EAST 3300 SOUIH #3B Salt Lake City,  UT  84109 -2106
Product CodeBZH  
CFR Regulation Number868.1860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-27
Decision Date1998-12-04
Summary:summary

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