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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Impedance
510(k) Number K911194
Device Name IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRAPH-DVT-2000
Applicant
Rjl Systems, Inc.
33955 Harper Ave.
Clinton Twp,  MI  48035
Correspondent
Rjl Systems, Inc.
33955 Harper Ave.
Clinton Twp,  MI  48035
Regulation Number870.2770
Classification Product Code
DSB  
Date Received03/18/1991
Decision Date 09/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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