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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Blood-Pressure, Extravascular
510(k) Number K851987
Device Name FLUSH DEVICE, AUTOMATIC
Applicant
Transamerica Delaval, Inc.
325 Halstead St.
P.O. Bin 7087
Pasadena,  CA  91109
Applicant Contact RICHARD G EKSTROM
Correspondent
Transamerica Delaval, Inc.
325 Halstead St.
P.O. Bin 7087
Pasadena,  CA  91109
Correspondent Contact RICHARD G EKSTROM
Regulation Number870.2850
Classification Product Code
DRS  
Date Received05/07/1985
Decision Date 08/16/1985
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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