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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 K864487
Device Name LIFEWATCH SENSOR BELT
Applicant
Lifewatch Systems, Inc.
Medical Device Consultants
45 W. St., Suite 2
Attleboro,  MA  02703
Applicant Contact WILLIAM A MORTON
Correspondent
Lifewatch Systems, Inc.
Medical Device Consultants
45 W. St., Suite 2
Attleboro,  MA  02703
Correspondent Contact WILLIAM A MORTON
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received11/13/1986
Decision Date 01/28/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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