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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Thermodilution
510(k) Number K915627
Device Name PACEVIEW
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 Number870.1915
Classification Product Code
KRB  
Date Received12/09/1991
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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