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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 K921068
Device Name GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300
Applicant
DATRIX
1312 GARY LN.
ESCONDIDO,  CA  92026
Applicant Contact JON BARRON
Correspondent
DATRIX
1312 GARY LN.
ESCONDIDO,  CA  92026
Correspondent Contact JON BARRON
Regulation Number870.2800
Classification Product Code
DSH  
Date Received03/06/1992
Decision Date 03/30/1992
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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