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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ballistocardiograph
510(k) Number K870442
Device Name QUANTASCOPE
Applicant
Vital Science Corp.
Boettcher Bldg. Suite 625
8400 E. Prentice Ave.
Englewood,  CO  80111
Applicant Contact DONALD J ZAHORIK
Correspondent
Vital Science Corp.
Boettcher Bldg. Suite 625
8400 E. Prentice Ave.
Englewood,  CO  80111
Correspondent Contact DONALD J ZAHORIK
Regulation Number870.2320
Classification Product Code
DXR  
Date Received02/03/1987
Decision Date 08/11/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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