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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K851123
Device Name R-1000 ECG RECEIVER
Applicant
BRENTWOOD INSTRUMENTS, INC.
2909 OREGON COURT
TORRANCE,  CA  90503
Applicant Contact DEL FREEMAN
Correspondent
BRENTWOOD INSTRUMENTS, INC.
2909 OREGON COURT
TORRANCE,  CA  90503
Correspondent Contact DEL FREEMAN
Regulation Number870.2920
Classification Product Code
DXH  
Date Received03/19/1985
Decision Date 05/15/1985
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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