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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Paper Chart
510(k) Number K822978
Device Name MINGOGRAF 4, MINGO CARD 4 & MINOCARD 3
Applicant
Siemens Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Siemens Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.2810
Classification Product Code
DSF  
Date Received10/08/1982
Decision Date 12/15/1982
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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