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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K040069
Device Name DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR
Applicant
DYMEDIX, INC.
800 LEVANGER LN.
STOUGHTON,  WI  53589
Applicant Contact Gary Syring
Correspondent
CITECH
5200 BUTLER PIKE
PLYMOUTH MEETING,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number868.2375
Classification Product Code
MNR  
Date Received01/14/2004
Decision Date 05/05/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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