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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 K921074
Device Name BP PUMP
Applicant
BIO-TEK INSTRUMENTS, INC.
HIHGLAND PARK
BOX 998
WINOOSKI,  VT  05404
Applicant Contact MICHAEL N SEVIGNY
Correspondent
BIO-TEK INSTRUMENTS, INC.
HIHGLAND PARK
BOX 998
WINOOSKI,  VT  05404
Correspondent Contact MICHAEL N SEVIGNY
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/06/1992
Decision Date 10/09/1992
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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