RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S

Monitor, Breathing Frequency

DYMEDIX, INC.

The following data is part of a premarket notification filed by Dymedix, Inc. with the FDA for Respiratory Belt Sensor, Model 6000s; Limb Movement Sensor, Model 3000s.

Pre-market Notification Details

Device IDK001030
510k NumberK001030
Device Name:RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S
ClassificationMonitor, Breathing Frequency
Applicant DYMEDIX, INC. 800 LEVANGER LN. Stoughton,  WI  53589
ContactGary Syring
CorrespondentGary Syring
DYMEDIX, INC. 800 LEVANGER LN. Stoughton,  WI  53589
Product CodeBZQ  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-30
Decision Date2000-05-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.