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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 K904109
Device Name BIO-IMPEDANCE ANALYZER
Applicant
Xitron Technologies, Inc.
10225 Barnes Canyon Rd.
A102
San Diego,  CA  92121
Applicant Contact JAMES MATTHIE
Correspondent
Xitron Technologies, Inc.
10225 Barnes Canyon Rd.
A102
San Diego,  CA  92121
Correspondent Contact JAMES MATTHIE
Regulation Number870.2770
Classification Product Code
DSB  
Date Received09/06/1990
Decision Date 01/08/1991
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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