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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K844977
Device Name HOLTER CURA-LITE RECORDER
Applicant
CARDIONOSTICS, INC.
1562 PARKWAY LOOP SUITE D
TUSTIN,  CA  92680
Applicant Contact MICHAEL HALVERSON
Correspondent
CARDIONOSTICS, INC.
1562 PARKWAY LOOP SUITE D
TUSTIN,  CA  92680
Correspondent Contact MICHAEL HALVERSON
Regulation Number870.2800
Classification Product Code
DSH  
Date Received12/26/1984
Decision Date 01/14/1985
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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