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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 K992772
Device Name CARDIOPHONICS 1000 MEMORY MONITOR
Applicant
Rlt Medical Assoc., Inc.
9620 Deereco Rd.
Timonium,  MD  21093
Applicant Contact RICHARD L TRADER
Correspondent
Rlt Medical Assoc., Inc.
9620 Deereco Rd.
Timonium,  MD  21093
Correspondent Contact RICHARD L TRADER
Regulation Number870.2920
Classification Product Code
DXH  
Date Received08/18/1999
Decision Date 09/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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