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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 K830489
Device Name RECORDER DMI
Applicant
Diagnostic Medical Instruments
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Diagnostic Medical Instruments
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.2800
Classification Product Code
DSH  
Date Received02/15/1983
Decision Date 05/25/1983
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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