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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 K840488
Device Name LIFECYCLE AEROBIC MONITOR 123
Applicant
HEART RATE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HEART RATE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received02/06/1984
Decision Date 05/30/1984
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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