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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 K900130
Device Name MODIFIED SEISMOCARDIOGRAPH
Applicant
Seismed Instruments, Inc.
13700 First Ave. N.
Minneapolis,  MN  55441
Applicant Contact SANDRA J GARLOUGH
Correspondent
Seismed Instruments, Inc.
13700 First Ave. N.
Minneapolis,  MN  55441
Correspondent Contact SANDRA J GARLOUGH
Regulation Number870.2770
Classification Product Code
DSB  
Date Received01/05/1990
Decision Date 03/28/1990
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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