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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 K854705
Device Name INFAGUARD TM
Applicant
LIFEWATCH SYSTEMS, INC.
8937 S.E. JANNSEN RD.
CLACKAMAS,  OR  97015
Applicant Contact FREDA WHITESEL
Correspondent
LIFEWATCH SYSTEMS, INC.
8937 S.E. JANNSEN RD.
CLACKAMAS,  OR  97015
Correspondent Contact FREDA WHITESEL
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received11/21/1985
Decision Date 05/01/1986
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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