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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 K864419
Device Name LIFEWATCH(R) PORTABLE MONITORING SYSTEM
Applicant
LIFEWATCH SYSTEMS, INC.
MEDICAL DEVICE CONSULTANTS
45 WEST STREET, SUITE 2
ATTLEBORO,  MA  02703
Applicant Contact WILLIAM A MORTON
Correspondent
LIFEWATCH SYSTEMS, INC.
MEDICAL DEVICE CONSULTANTS
45 WEST STREET, SUITE 2
ATTLEBORO,  MA  02703
Correspondent Contact WILLIAM A MORTON
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received11/10/1986
Decision Date 03/16/1987
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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