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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K850893
Device Name BP/CLINIC SYS MEASUREMENT, BP NON-INVASIVE
Applicant
Sun Dance Technology, Inc.
6500 Papermill Rd.
Knoxville,  TN  37919
Applicant Contact JON D SCHAFFER
Correspondent
Sun Dance Technology, Inc.
6500 Papermill Rd.
Knoxville,  TN  37919
Correspondent Contact JON D SCHAFFER
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/04/1985
Decision Date 05/16/1985
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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