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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K001030
Device Name RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S
Applicant
DYMEDIX, INC.
800 LEVANGER LN.
STOUGHTON,  WI  53589
Applicant Contact Gary Syring
Correspondent
DYMEDIX, INC.
800 LEVANGER LN.
STOUGHTON,  WI  53589
Correspondent Contact Gary Syring
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received03/30/2000
Decision Date 05/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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