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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 K862383
Device Name MODIFIED MODEL BIA-103 BODY COMPOSITION ANALYZER
Applicant
Rjl Systems, Inc.
9930 Whittier
Detroit,  MI  48224
Applicant Contact RUDOLPH J LIEDTKE
Correspondent
Rjl Systems, Inc.
9930 Whittier
Detroit,  MI  48224
Correspondent Contact RUDOLPH J LIEDTKE
Regulation Number870.2770
Classification Product Code
DSB  
Date Received06/24/1986
Decision Date 02/03/1987
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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