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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 K892323
Device Name SEISMOCARDIOGRAPH - SCG(TM) 1000 SERIES
Applicant
Seismed Instruments, Inc.
825 So. 8th St., Suite 320
Minneapolis,  MN  55404
Applicant Contact SANDRA J GARLOUGH
Correspondent
Seismed Instruments, Inc.
825 So. 8th St., Suite 320
Minneapolis,  MN  55404
Correspondent Contact SANDRA J GARLOUGH
Regulation Number870.2770
Classification Product Code
DSB  
Date Received04/06/1989
Decision Date 10/30/1989
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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