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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 K902042
Device Name EM-SCAN HP-2 PEDIATRIC BODY COMPOSITION ANALYZER
Applicant
Em-Scan, Inc.
1150 17th St., NW
Suite 1000
Washington,  DC  20036
Applicant Contact MARK A SIEVERS
Correspondent
Em-Scan, Inc.
1150 17th St., NW
Suite 1000
Washington,  DC  20036
Correspondent Contact MARK A SIEVERS
Regulation Number870.2770
Classification Product Code
DSB  
Date Received05/04/1990
Decision Date 07/26/1990
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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