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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K915624
Device Name MODIFIED BIOLOG
Applicant
Micromedical Industries, Ltd.
255 Revere Dr.
Suite 101
Northbrook,  IL  60062
Applicant Contact EDWARD HAWFIELD
Correspondent
Micromedical Industries, Ltd.
255 Revere Dr.
Suite 101
Northbrook,  IL  60062
Correspondent Contact EDWARD HAWFIELD
Regulation Number870.2300
Classification Product Code
DRT  
Date Received12/05/1991
Decision Date 03/27/1992
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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