CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR

Monitor, Breathing Frequency

PRO-TECH, INC.

The following data is part of a premarket notification filed by Pro-tech, Inc. with the FDA for Crystal Trace Piezo Respiratory Effort Sensor.

Pre-market Notification Details

Device IDK923402
510k NumberK923402
Device Name:CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR
ClassificationMonitor, Breathing Frequency
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 CodeBZQ  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-10
Decision Date1992-12-30

NIH GUDID Devices

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