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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 K903300
Device Name RESP-EZ(TM) RESPIRATORY MONITORING BELT
Applicant
EPM INFORMATION SYSTEMS, INC.
934 PLEASANT STREET, SUITE 1
OAK PARK,  IL  60302
Applicant Contact STEPHEN A BURTON
Correspondent
EPM INFORMATION SYSTEMS, INC.
934 PLEASANT STREET, SUITE 1
OAK PARK,  IL  60302
Correspondent Contact STEPHEN A BURTON
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received07/24/1990
Decision Date 12/28/1990
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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