RESPIRATORY SENSOR (MODEL 409 W/NASOPH.)

Monitor, Breathing Frequency

IMPACT INSTRUMENTATION, INC.

The following data is part of a premarket notification filed by Impact Instrumentation, Inc. with the FDA for Respiratory Sensor (model 409 W/nasoph.).

Pre-market Notification Details

Device IDK811265
510k NumberK811265
Device Name:RESPIRATORY SENSOR (MODEL 409 W/NASOPH.)
ClassificationMonitor, Breathing Frequency
Applicant IMPACT INSTRUMENTATION, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeBZQ  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-05-12
Decision Date1981-06-02

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