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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 K881272
Device Name ACCUSTAT MODEL 102 NON-INVASIVE BLOOD MONITORING
Applicant
Accustat, Inc.
1944 "C" Calumet St.
Clearwater,  FL  33575
Applicant Contact LEE L LADD
Correspondent
Accustat, Inc.
1944 "C" Calumet St.
Clearwater,  FL  33575
Correspondent Contact LEE L LADD
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/24/1988
Decision Date 06/22/1988
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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