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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 K874898
Device Name CM 3000 THE MONITOR
Applicant
LIFELINE MEDICAL SYSTEMS, INC.
P.O. BOX 484
TUALATIN,  OR  97062
Applicant Contact FREDA WHITESEL
Correspondent
LIFELINE MEDICAL SYSTEMS, INC.
P.O. BOX 484
TUALATIN,  OR  97062
Correspondent Contact FREDA WHITESEL
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received12/01/1987
Decision Date 03/21/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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