EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS

Spirometer, Diagnostic

PRO-TECH, INC.

The following data is part of a premarket notification filed by Pro-tech, Inc. with the FDA for Ez-1 System Respiratory Effort Sensors.

Pre-market Notification Details

Device IDK913395
510k NumberK913395
Device Name:EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS
ClassificationSpirometer, Diagnostic
Applicant PRO-TECH, INC. P.O. BOX 2165 17710-134TH AVENUE N.E. Woodinville,  WA  98072
ContactRandy Carruthers
CorrespondentRandy Carruthers
PRO-TECH, INC. P.O. BOX 2165 17710-134TH AVENUE N.E. Woodinville,  WA  98072
Product CodeBZG  
CFR Regulation Number868.1840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-30
Decision Date1992-05-20

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